Full-Montage Standard Electroencephalograph
FDA product code GWQ · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
189510(k) clearances
0PMA approvals
21recalls
Manufacturers
- Nihon Kohden America, Inc. 15
- Excel Tech. , Ltd. 15
- Del Mar Avionics 7
- Oxford Medilog, Inc. 6
- Bio-Logic Systems Corp. 5
- Physiometrix, Inc. 5
- Teca, Inc. 5
- Electrical Geodesics, Incorporated 4
- Bioserenity Sas 4
- Cadwell Laboratories, Inc. 4
- Axon Systems, Inc. 4
- Cadwell Industries, Inc. 4
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 4
- Zeto, Inc. 3
- Neurovirtual USA, Inc. 3
- Grass-Telefactor Product Group 3
- Bio-Scan, Inc. 3
- Biosound, Inc. 3
- Mini-Mitter Co., Inc. 3
- Nihon Kohden Corporation 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special | Neuroelectrics Barcelona S.L.U. | 06/13/2026SE |
| K260455 | New Wave SystemGWQ · Special | Zeto, Inc. | 03/13/2026SE |
| K233403 | Flexset SystemGWQ · Traditional | Zeto, Inc. | 04/30/2024SE |
| K231366 | Neuronaute PlusGWQ · Traditional | Bioserenity Sas | 11/09/2023SE |
| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
| K221963 | Cumulus Functional Neurophysiology PlatformGWQ · Traditional | Cumulus Neuroscience Limited | 04/27/2023SE |
| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
| K220056 | iSyncWaveGWQ · Traditional | iMediSync, Inc. | 08/10/2022SE |
| K212788 | Seer HomeGWQ · Traditional | Seer Medical Pty, Ltd. | 06/16/2022SE |
| K213900 | WAVi SCAN EEG System and AccessoriesGWQ · Traditional | Wavi Co. | 05/06/2022SE |
| K193159 | NeuroAmp II, NeuroAmp II.5sGWQ · Traditional | Corscience GmbH & Co. KG | 12/30/2020SE |
| K202334 | NeuronauteGWQ · Traditional | Bioserenity Sas | 12/10/2020SE |
| K201819 | Cadwell Apollo SystemGWQ · Traditional | Cadwell Industries, Inc. | 09/29/2020SE |
| K191492 | Maxxi Position SensorGWQ · Traditional | Neurovirtual USA, Inc. | 04/24/2020SE |
| K191868 | iCEWav Neuromonitoring PlatformGWQ · Traditional | Ice Neurosystems, Inc. | 03/31/2020SE |
| K192753 | NeuralScan SystemGWQ · Traditional | Medeia, Inc. | 03/17/2020SE |
| K181466 | Cadwell Zenith SystemGWQ · Traditional | Cadwell Industries, Inc. | 09/01/2018SE |
| K180269 | Cadwell Apollo SystemGWQ · Traditional | Cadwell Industries, Inc. | 07/17/2018SE |
| K180290 | Natus Brain Monitor AmplifierGWQ · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 06/14/2018SE |
| K172271 | Trackit T4 EEG AmplifierGWQ · Traditional | Lifelines , Ltd. | 05/04/2018SE |
| K172735 | WR19 SystemGWQ · Traditional | Zeto, Inc. | 04/17/2018SE |
| K180181 | Natus QuantumGWQ · Special | Natus Medical Incorporated Dba Excel_Tech Ltd.… | 02/22/2018SE |
| K173460 | NeuroEEGGWQ · Traditional | Memory MD, Inc. | 02/16/2018SE |
| K171384 | Micromed BRAIN QUICK systemGWQ · Traditional | Micromed S.P.A. | 02/01/2018SE |
| K170138 | NeuronauteGWQ · Traditional | Bioserenity | 12/26/2017SE |
| K171781 | eVox SystemGWQ · Traditional | Evoke Neuroscience, Inc. | 12/13/2017SE |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200GWQ · Traditional | Nihon Kohden Corporation | 08/25/2017SE |
| K170441 | ElectroTekGWQ · Traditional | Mobilemedtek | 06/05/2017SE |
| K162681 | Enobio Wireless EEGGWQ · Traditional | Neuroelectrics Barcelona S.L.U. | 06/02/2017SE |
| K163163 | XLTEK EMU40EX EEG HeadboxGWQ · Special | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 12/14/2016SE |
| K162595 | Trex_HDGWQ · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 11/04/2016SE |
| K150498 | Discovery 24GWQ · Traditional | Brainmaster Technologies, Inc. | 01/26/2016SE |
| K143233 | Mitsar-EEGGWQ · Traditional | Mitsar Co., Ltd. | 08/13/2015SE |
| K143440 | Natus QuantumGWQ · Traditional | Natus Medical Incorporated | 04/20/2015SE |
| K131335 | Bwmini EEG, Bwminihst, Bwmini PSGGWQ · Traditional | Neurovirtual USA, Inc. | 02/03/2015SE |
| K131266 | Trez_HdGWQ · Traditional | Excel-Tech Ltd. (Xltek) | 02/14/2014SE |
| K133355 | Cadwell Flex Eeg/PsgGWQ · Traditional | Cadwell Industries, Inc. | 01/29/2014SE |
| K131383 | X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareGWQ · Traditional | Advanced Brain Monitoring, Inc. | 11/27/2013SE |
| K122196 | Cervello Bio-Potential Signal Acquistion System Product FamilyGWQ · Traditional | Blackrock Neuromed, LLC | 05/02/2013SE |
| K120888 | PSG-1100 Sleep Diagnostic SystemGWQ · Special | Nihon Kohden Corp. | 11/09/2012SE |
| K112817 | Microeeg SystemGWQ · Traditional | Bio-Signal Group Corporation | 06/19/2012SE |
| K113117 | Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction BoxGWQ · Special | Nihon Kohden America, Inc. | 03/22/2012SE |
| K112353 | Geodesic EEG Mobile 100 (Gem 100)GWQ · Traditional | Electrical Geodesics, Inc. | 02/17/2012SE |
| K112107 | Bwiii EEG, Bwiii EEG Plus, Bwiii PSG, Bwiii PSG PlusGWQ · Traditional | Neurovirtual USA, Inc. | 10/28/2011SE |
| K083577 | Harmonie SystemGWQ · Abbreviated | Stellate Systems | 08/29/2011SE |
| K110376 | PE-210AK Switch BoxGWQ · Traditional | Nihon Kohden Corp. | 07/29/2011SE |
| K103129 | Entropy Easyfit SensorGWQ · Traditional | GE Healthcare | 07/19/2011SE |
| K101386 | Vigilant EEG Monitor Model Vigilant 2.0GWQ · Special | Infinite Biomedical Technologies, LLC | 07/30/2010SE |
| K100683 | Neurolink Ip Model: PK1117GWQ · Special | Natus Medical Incorporated | 04/09/2010SE |
| K093223 | Compumedics Grael System, Models: Grael, Grael ECGGWQ · Traditional | Compumedics Limited | 01/15/2010SE |
| K081741 | Neurolink Ip, Model PK1113GWQ · Traditional | Excel-Tech Ltd. (Xltek) | 10/31/2008SE |
| K081151 | Compumedics NeuvoGWQ · Special | Compumedics USA, Ltd. | 09/08/2008SE |
| K071109 | Sacs EEG Workstation A7GWQ · Traditional | Sacs Medical AB | 06/07/2007SE |
| K061908 | Nicoletone System V32 AmplifierGWQ · Abbreviated | Viasys Neuro Care | 11/06/2006SE |
| K053386 | Xltek EMU40 EEG Headbox, Model PK1072GWQ · Traditional | Excel Tech. , Ltd. | 04/21/2006SE |
| K051825 | CognitraceGWQ · Traditional | Eemagine Medical Imaging Solutions GmbH | 09/12/2005SE |
| K042626 | Neuroport Neural Signal Processor (NSP) SystemGWQ · Traditional | Cyberkinetics, Inc. | 03/28/2005SE |
| K043309 | Geodesic Photogrammetry SystemGWQ · Traditional | Electrical Geodesics, Incorporated | 01/26/2005SE |
| K042150 | Xltek Trex MODEL#10309GWQ · Special | Excel Tech. , Ltd. | 08/27/2004SE |
| K033399 | Geodesic EEG System Series 100GWQ · Traditional | Electrical Geodesics, Incorporated | 08/04/2004SE |
| K040554 | Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256GWQ · Abbreviated | Manufacturing Technology, Inc. | 07/16/2004SE |
| K040360 | EMU128S, Model EX-NW-128SGWQ · Special | Excel Tech. , Ltd. | 03/12/2004SE |
| K033978 | AdamGWQ · Traditional | Astro-Med, Inc. | 02/18/2004SE |
| K023771 | SYNAMPS2GWQ · Abbreviated | Neuroscan | 02/06/2003SE |
| K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationGWQ · Special | Axon Systems, Inc. | 10/09/2002SE |
| K021599 | 96 Channel EEG Headbox Model EMU96GWQ · Traditional | Excel Tech. , Ltd. | 08/13/2002SE |
| K014147 | 80 Channel EEGGWQ · Special | Xltek | 01/14/2002SE |
| K014146 | 84 Channel EEGGWQ · Special | Xltek | 01/14/2002SE |
| K010997 | Pam-RlGWQ · Traditional | Individual Monitoring Systems, Inc. | 10/15/2001SE |
| K012079 | Geodesic EEG System, Model 200GWQ · Traditional | Electrical Geodesics, Incorporated | 09/19/2001SE |
| K010697 | Unique Ambulatory EEGGWQ · Traditional | Axon Systems, Inc. | 06/06/2001SE |
| K010669 | Neurograph Evoked Potential Systems (Eps), Model EPS-1GWQ · Traditional | Thuris Corp. | 06/04/2001SE |
| K011430 | Actiware-PlmsGWQ · Special | Mini-Mitter Co., Inc. | 05/31/2001SE |
| K010086 | Real Patient Excel Neurowork, Model Ex-Rp-Eeg (Proposed)GWQ · Traditional | Excel Tech. , Ltd. | 04/09/2001SE |
| K010089 | Real Patient Wireless Ambulatory EEG, Model Ex-Amb-Wireless-Rp (Proposed)GWQ · Traditional | Excel Tech. , Ltd. | 03/26/2001SE |
| K010088 | Real Patient Ambulatory EEG, Model Ex-Amb-Rp (Proposed)GWQ · Traditional | Excel Tech. , Ltd. | 03/26/2001SE |
| K010084 | Real Patient Real Patient 128 Channel EEG Headbox, Model EX-NW-128-RPGWQ · Traditional | Excel Tech. , Ltd. | 03/16/2001SE |
| K010150 | 64 Channel EEG / Model Number EX-NW-64GWQ · Special | Excel Tech. , Ltd. | 02/09/2001SE |
| K010091 | EEG with Video, Model Ex-NwGWQ · Special | Excel Tech. , Ltd. | 02/01/2001SE |
| K002316 | Phoenix Digital EEGGWQ · Traditional | Axon Systems, Inc. | 10/26/2000SE |
| K002570 | Bio-Logic Ceegraph NetlinkGWQ · Special | Bio-Logic Systems Corp. | 09/14/2000SE |
| K000919 | 128 Channel EEG Headbox, Model EX-NW-128GWQ · Traditional | Excel Tech. , Ltd. | 08/31/2000SE |
| K001103 | Wireless Ambulatory EEG, Model Ex-Amb-Wireless (Proposed)GWQ · Traditional | Excel Tech. , Ltd. | 06/30/2000SE |
| K000898 | EEG with Video, Model Ex-NwGWQ · Special | Excel Tech. , Ltd. | 04/14/2000SE |
| K991054 | Bravo Multi-Modality SystemGWQ · Traditional | Nicolet Biomedical, Inc. | 11/03/1999SE |
| K992410 | ActitracGWQ · Traditional | Individual Monitoring Systems, Inc. | 10/15/1999SE |
| K991033 | Actiwatch-ScoreGWQ · Traditional | Mini-Mitter Co., Inc. | 06/23/1999SE |
| K983533 | ActiwatchGWQ · Traditional | Mini-Mitter Co., Inc. | 03/23/1999SE |
| K982479 | Excel Ambulatory EEGGWQ · Traditional | Excel Tech. , Ltd. | 10/14/1998SE |
| K980214 | Excel Neuro WorksGWQ · Traditional | Excel Tech. , Ltd. | 04/21/1998SE |
| K973883 | Bio-Logic Ceegraph 128-CHANNEL Recording SystemGWQ · Traditional | Bio-Logic Systems Corp. | 03/05/1998SE |
| K974495 | Neuroamp EEG AmplifierGWQ · Traditional | Neurocorp, Ltd. | 02/26/1998SE |
| K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional EEG Subsystem)GWQ · Traditional | Ctf Systems, Inc. | 11/20/1997SE |
| K972202 | Deeg-LiteGWQ · Traditional | Grass-Telefactor Product Group | 07/23/1997SE |
| K971331 | SatelliteGWQ · Traditional | Nicolet Biomedical, Inc. | 06/25/1997SE |
| K970942 | Model 1320, Neurolink II Neuromonitoring SystemGWQ · Traditional | Physiometrix, Inc. | 06/02/1997SE |
| K970703 | Galileo HalleyGWQ · Traditional | Biosound Esaote, Inc. | 05/19/1997SE |
| K964280 | DG NervusGWQ · Traditional | Medelec , Ltd. | 01/27/1997SE |
| K961642 | Medilog MR95GWQ · Traditional | Oxford Instruments, Plc. | 01/17/1997SE |
| K962447 | Equinox Digital EEG SystemGWQ · Traditional | Physiometrix, Inc. | 12/12/1996SE |
| K962157 | Model 1310 Neurolink Neuromonitoring SystemGWQ · Traditional | Physiometrix, Inc. | 11/25/1996SE |
| K954954 | Ceegraph Traveler Ambulatory EEG RecorderGWQ · Traditional | Bio-Logic Systems Corp. | 01/25/1996SE |
| K953449 | Model 1207, Hydrodot Neuromonitoring System Adhesive PadsGWQ · Traditional | Physiometrix, Inc. | 10/12/1995SE |
| K946094 | Cadwell Easy Ambulatory EEGGWQ · Traditional | Cadwell Laboratories, Inc. | 09/12/1995SE |
| K951507 | Principle Component EEG Analysis SoftwareGWQ · Traditional | Neuroconcepts, Inc. | 07/14/1995SE |
| K944678 | Nihon Kohden ElectroencephalographGWQ · Traditional | Nihon Kohden America, Inc. | 05/22/1995SE |
| K941551 | The Vanguard SystemGWQ · Traditional | Cleveland Clinic Foundation | 01/13/1995SE |
| K934670 | DG 3P SystemGWQ · Traditional | Medelec , Ltd. | 05/25/1994SE |
| K932407 | Cadwell Easy Writer and Easy ReaderGWQ · Traditional | Cadwell Laboratories, Inc. | 03/22/1994SE |
| K933233 | Ceegraph, ModificationGWQ · Traditional | Bio-Logic Systems Corp. | 03/03/1994SE |
| K932842 | Spacelabs Medical Model 90481 EEG ModuleGWQ · Traditional | Spacelabs Medical, Inc. | 03/02/1994SE |
| K933951 | Video EEG Option ModificationGWQ · Traditional | Esaote Biomedica Spa | 02/03/1994SE |
| K930080 | E*Net Neuromonitoring SystemGWQ · Traditional | Physiometrix, Inc. | 10/19/1993SE |
| K924179 | EEG Model 24/32GWQ · Traditional | Lama Engineering, Inc. | 06/22/1993SE |
| K921138 | Nicolet Ultrasom Acquisition StationGWQ · Traditional | Nicolet Instrument Corp. | 05/14/1993SE |
| K925838 | Telefactor D/EEG-32GWQ · Traditional | Grass-Telefactor Product Group | 04/30/1993SE |
| K923894 | Yhe Galileo Pleiade ElectroencephalographGWQ · Traditional | Biosound, Inc. | 03/10/1993SE |
| K923860 | The Galileo Line -- Planet 100, 200 & 300 & StarGWQ · Traditional | Biosound, Inc. | 02/04/1993SE |
| K923950 | The Galileo VEGA-24 ElectroencephalographGWQ · Traditional | Biosound, Inc. | 01/26/1993SE |
| K921927 | Nicolet VoyageurGWQ · Traditional | Nicolet Instrument Corp. | 11/05/1992SE |
| K922548 | Medelec 2110 and 2114 EEGGWQ · Traditional | Medelec Intl. Corp. | 11/03/1992SE |
| K921485 | La Mont Video Patient Monitoring SystemGWQ · Traditional | Medical Systems Corp. | 10/22/1992SE |
| K920127 | Electroencephalograph Recording SystemGWQ · Traditional | Medelec Intl. Corp. | 06/10/1992SE |
| K915096 | Neurofax EEG 5532GWQ · Traditional | Nihon Kohden America, Inc. | 03/11/1992SE |
| K914571 | Neurotrac IIGWQ · Traditional | Moberg Medical, Inc. | 01/30/1992SE |
| K910972 | Walter GraphtekGWQ · Traditional | Inomed Medizintechnik GmbH | 10/02/1991SE |
| K911229 | Phoenix Digital EEG SystemGWQ · Traditional | Dantec Medical, Inc. | 09/30/1991SE |
| K910279 | Mcseer/Micro Controller SLD ST EEG Event RecorderGWQ · Traditional | New England Medical Instruments, Inc. | 09/04/1991SE |
| K910945 | Horizon 2000 EEG Monitoring OptionGWQ · Traditional | Mennen Medical, Inc. | 08/15/1991SE |
| K905435 | UniquantGWQ · Traditional | Neuroconcepts, Inc. | 07/22/1991SE |
| K904269 | NEUROSEARCH-24 or NRS-24GWQ · Traditional | Lexicor Medical Technology, Inc. | 06/04/1991SE |
| K904763 | Mentor EEG SystemGWQ · Traditional | Oxford Medilog, Inc. | 04/10/1991SE |
| K902550 | EEG-5400 SeriesGWQ · Traditional | Nihon Kohden America, Inc. | 03/19/1991SE |
| K902752 | Neuritor 2001GWQ · Traditional | Imexco General , Ltd. | 12/04/1990SE |
| K903004 | EE1114, 1118, 1121 Electro-EncephalographGWQ · Traditional | Teca, Inc. | 11/15/1990SE |
| K901549 | CNS Satellite 100, 200, 1000, 2000 Electroence.GWQ · Traditional | Cns, Inc. | 10/24/1990SE |
| K896942 | Spacelabs Model 90480 EEG ModuleGWQ · Traditional | Spacelabs, Inc. | 03/08/1990SE |
| K896666 | P460, DG32 ElectroencephalographGWQ · Traditional | Teca, Inc. | 02/16/1990SE |
| K895125 | CeegraphGWQ · Traditional | Bio-Logic Systems Corp. | 12/22/1989SE |
| K894044 | ActillumeGWQ · Traditional | Ambulatory Monitoring, Inc. | 12/22/1989SE |
| K894276 | Cadwell Freedom EEG DeviceGWQ · Traditional | Cadwell Laboratories, Inc. | 09/29/1989SE |
| K890881 | Teca 1A96, 1A97 and 1A98 ElectroencephalographsGWQ · Traditional | Teca, Inc. | 03/23/1989SE |
| K884537 | AE-800PA EEG ModuleGWQ · Traditional | Nihon Kohden America, Inc. | 12/29/1988SE |
| K883557 | Neurowave System 2GWQ · Traditional | Durden Enterprises, Inc. | 12/16/1988SE |
| K870815 | Kontron E.E.G. Monitor, Supermon Module 7265GWQ · Traditional | Kontron Instruments, Inc. | 02/01/1988SE |
| K874796 | Model EEG 4400 with Optional AccessoriesGWQ · Traditional | Nihon Kohden America, Inc. | 01/19/1988SE |
| K873535 | Nicolet Expert Sleep/Wake Analysis SystemGWQ · Traditional | Nicolet Biomedical Instruments | 10/26/1987SE |
| K872183 | Ambulatory EEG PlaybackGWQ · Traditional | Cadwell Laboratories, Inc. | 07/21/1987SE |
| K871500 | Model 5000 Ambulatory Monitoring SystemGWQ · Traditional | Oxford Medilog, Inc. | 07/01/1987SE |
| K870432 | A1-A2 Ambulatory EEG Cassette RecorderGWQ · Traditional | Grass-Telefactor Product Group | 05/08/1987SE |
| K870263 | Neuromapper 1620GWQ · Traditional | Neuroscience, Inc. | 04/10/1987SE |
| K864928 | Bio-Log 8+1 Ambulatory Physiologic RecorderGWQ · Traditional | Bio-Scan, Inc. | 03/31/1987SE |
| K863193 | Sentinel 4 EEG AnalyzerGWQ · Traditional | Axon Systems, Inc. | 12/02/1986SE |
| K863124 | Model 8 EEG PreamplifierGWQ · Traditional | Micro Tronics Corp. | 11/18/1986SE |
| K863749 | Teca/Ecem T5 Portable ElectroencephalographGWQ · Traditional | Teca, Inc. | 10/06/1986SE |
| K854663 | Neurofax 7310 Series (EEG)GWQ · Traditional | Nihon Kohden America, Inc. | 08/20/1986SE |
| K860456 | Model 9000 Recording & Electrophysiological SystemGWQ · Traditional | Oxford Medilog, Inc. | 08/11/1986SE |
| K854030 | Wrist ActigraphGWQ · Traditional | Ambulatory Monitoring, Inc. | 06/25/1986SE |
| K854268 | Del Mar Avionics 5509A Physioscanner EEG ScannerGWQ · Traditional | Del Mar Avionics | 03/27/1986SE |
| K851232 | Teca Montage IIGWQ · Traditional | Teca, Inc. | 06/13/1985SE |
| K850418 | Bushel Off-Head PreamplifierGWQ · Traditional | Oxford Medilog, Inc. | 06/13/1985SE |
| K850259 | Electroencephalograph EEGGWQ · Traditional | Nicolet Biomedical Instruments | 04/11/1985SE |
| K842784 | CeregrotracGWQ · Traditional | Advanced Instruments, Inc. | 01/10/1985SE |
| K841653 | Del Mar Avionics 5509 Neuro-ScannerGWQ · Traditional | Del Mar Avionics | 12/03/1984SE |
| K842714 | EEG-4300 W/Optinal Access. EEG 4314 &GWQ · Traditional | Nihon Kohden America, Inc. | 09/25/1984SE |
| K841684 | Bio/Scan Biolog Cassette RecorderGWQ · Traditional | Bio-Scan, Inc. | 06/07/1984SE |
| K841683 | Q.P. Preamplifier SysGWQ · Traditional | Bio-Scan, Inc. | 06/07/1984SE |
| K831324 | EEG 42/2P Electro EncephalographGWQ · Traditional | Nihon Kohden America, Inc. | 05/27/1983SE |
| K830295 | Medilog 9000 SystemGWQ · Traditional | Oxford Medilog, Inc. | 03/24/1983SE |
| K823140 | ElectroencephalographGWQ · Traditional | Nihon Kohden America, Inc. | 12/07/1982SE |
| K823116 | NeurotracGWQ · Traditional | Interspec, Inc. | 12/07/1982SE |
| K822700 | Del Mar Model 5500 EEG ScannerGWQ · Traditional | Del Mar Avionics | 10/04/1982SE |
| K820779 | Ote Biomedical #1296 - 16 Chan. RecordGWQ · Traditional | Del Mar Avionics | 04/26/1982SE |
| K820605 | Ote Biomedica Neurograph 18GWQ · Traditional | Del Mar Avionics | 03/23/1982SE |
| K820604 | Ote Biomedica Neurograph 9GWQ · Traditional | Del Mar Avionics | 03/23/1982SE |
| K820603 | Ote Biomedica Neurograph 14GWQ · Traditional | Del Mar Avionics | 03/23/1982SE |
| K820066 | Electroencephalographs EEG-5208,5210GWQ · Traditional | Nihon Kohden America, Inc. | 02/04/1982SE |
| K802887 | Model EEG 4221GWQ · Traditional | Nihon Kohden America, Inc. | 12/16/1980SE |
| K802296 | Mingograf EEG10GWQ · Traditional | Siemens Corp. | 10/03/1980SE |
| K802292 | Mingograf EEG21GWQ · Traditional | Siemens Corp. | 10/03/1980SE |
| K791234 | Model EEG-4217 ElectroencephalographGWQ · Traditional | Nihon Kohden America, Inc. | 09/12/1979SE |
| K791233 | Model EEG-4214 ElectroencephalographGWQ · Traditional | Nihon Kohden America, Inc. | 09/12/1979SE |
| K791150 | Electroencephalographs Models 7209,7213GWQ · Traditional | Nihon Kohden America, Inc. | 09/12/1979SE |
| K781129 | Accessory to 4-24 RecorderGWQ · Traditional | Oxford Medilog, Inc. | 08/31/1978SE |
| K781041 | Electroencephalograph Accutrace 100GWQ · Traditional | Beckman Instruments, Inc. | 06/28/1978SE |
| K781005 | Electroencephalograph Accutrate 200GWQ · Traditional | Beckman Instruments, Inc. | 06/28/1978SE |
| K770246 | Isolated EEG Amplifier ModuleGWQ · Traditional | Mennen Greatbatch Electonics | 02/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2353-2026 Class II | SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software…Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from… | Micromed S.p.A. | 05/04/2026Open, Classified |
| Z-2138-2025 Class II | Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard…Natus received two complaints of left side labeling show impedance for right side. | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 06/18/2025Open, Classified |
| Z-3143-2024 Class II | Seer Home System is an ambulatory electroencephalograph (EEG) system intended for…During CAPA investigations of sight production inconsistencies, it was highlighted that previous… | Seer Medical Pty Ltd | 08/12/2024Open, Classified |
| Z-1942-2024 Class II | WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software…Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components… | WAVi Co. | 12/08/2023Open, Classified |
| Z-0865-2021 Class II | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS…Medical device non-conformance to electrical safety standard (IEC 60601-1). | Nihon Kohden America Inc | 12/21/2020Open, Classified |
| Z-0723-2020 Class II | ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The…Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having… | Lifelines Neuro Company | 10/11/2019Terminated |
| Z-0722-2020 Class II | ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The…Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having… | Lifelines Neuro Company | 10/11/2019Terminated |
| Z-2570-2018 Class II | XLTEK EMU40EX EEG HeadboxPossible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX… | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 05/15/2018Terminated |
| Z-0581-2016 Class II | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus…During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum… | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 11/11/2015Terminated |
| Z-0117-2016 Class II | NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data…When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the… | Natus Neurology Inc | 09/11/2015Terminated |
| Z-1256-2010 | NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software… | CareFusion | 03/08/2010Terminated |
| Z-0487-2012 | Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models…The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been… | Stellate Systems | 04/16/2009Terminated |
| Z-1080-2013 Class II | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system…The firm is initiating this recall because the implied or stated indications in their labeling associated… | Stellate Systems | 04/06/2009Terminated |
| Z-2459-2008 | NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM…NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient… | Cardinal Health NeuroCare Division | 06/13/2008Terminated |
| Z-2389-2008 | NicoletOne photic adapter cable 085-463700Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic… | Cardinal Health NeuroCare Division | 06/05/2008Terminated |
| Z-1057-2008 | Non-continuous ventilator accessories under the following brand names: a) Adult ECG…Foreign material: Glass fragments may present in the plastic bag material used to ship components. | Respironics, Inc. | 10/15/2007Terminated |
| Z-0126-2008 | Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing…Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital… | Nicolet Biomedical Div of Viasys Healthcare | 09/11/2007Terminated |
| Z-0001-2008 | Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and…Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during… | Bio-Logic Systems Corp | 07/26/2007Terminated |
| Z-1225-2007 | BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during…The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was… | Nicolet Biomedical Div of Viasys Healthcare | 07/17/2007Terminated |
| Z-0761-2007 | Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company…Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in… | Bio-Logic Systems Corp | 02/26/2007Terminated |
| Z-0380-2007 | NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used…A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using… | Nicolet Biomedical Div of Viasys Healthcare | 08/25/2006Terminated |