Standard Polysomnograph With Electroencephalograph
FDA product code OLV · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
65510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Nihon Kohden America, Inc. 9
- Neurotronics, Inc. 5
- Grass-Telefactor Product Group 4
- Bio-Logic Systems Corp. 3
- Lamont Medical, Inc. 2
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 2
- Stellate Systems 2
- Compumedics Limited 2
- Grass Instrument Co. 2
- Airsep Corp. 2
- Excel Tech. , Ltd. 2
- Biosys AB (Publ) 2
- Somnomedics GmbH 2
- Astro-Med, Inc. 2
- Nox Medical Ehf 2
- Oxford Medilog, Inc. 1
- Beacon Biosignals, Inc. 1
- Lifelines , Ltd. 1
- Sensor Medics Corp. 1
- Healthdyne, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261747 | Report StudioOLV · Traditional | Beacon Biosignals, Inc. | 08/25/2026SE |
| K260585 | Noxturnal WebOLV · Special | Nox Medical Ehf | 03/20/2026SE |
| K242447 | Falcon HSTOLV · Traditional | Compumedics Limited | 02/20/2025SE |
| K241288 | Noxturnal WebOLV · Traditional | Nox Medical Ehf | 12/23/2024SE |
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | Somnomedics GmbH | 12/08/2024SE |
| K213007 | Cerebra Sleep SystemOLV · Traditional | Cerebra Medical , Ltd. | 07/06/2022SE |
| K201054 | SOMNOscreen plusOLV · Traditional | Somnomedics GmbH | 08/12/2020SE |
| K192624 | ApneaTrakOLV · Traditional | Cadwell Industries, Inc. | 02/20/2020SE |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional | Neurotronics, Inc. | 11/16/2018SE |
| K173868 | Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional | Neurotronics, Inc. | 07/02/2018SE |
| K173690 | Grass TWinOLV · Special | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 03/09/2018SE |
| K172986 | Zmachine SynergyOLV · Traditional | Consolidated Research of Richmond, Inc. Dba… | 12/19/2017SE |
| K172711 | Comet-PLUSOLV · Special | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 11/03/2017SE |
| K161650 | Polysmith Sleep System, Model NTI7593OLV · Traditional | Neurotronics, Inc. | 01/19/2017SE |
| K142774 | Polysmith Sleep SystemOLV · Traditional | Neurotronics, Inc. | 02/18/2015SE |
| K131415 | Live View Panel (LVP)OLV · Traditional | Neurotronics, Inc. | 08/09/2013SE |
| K111055 | Galaxy System; JupiterOLV · Traditional | Personal Health Institute International | 12/21/2011SE |
| K101830 | Zmachine, Model DT-100OLV · Traditional | Consolidated Research of Richmond, Inc. | 03/31/2011SE |
| K093728 | Be Micro, TreaOLV · Traditional | Eb Neuro S.P.A. | 04/29/2010SE |
| K073491 | EEG-1100A Switch BoxOLV · Special | Nihon Kohden America, Inc. | 01/11/2008SE |
| K071782 | Micromed Brain Spy Plus, Embia Titanium DevicesOLV · Abbreviated | Micromed S.P.A. | 01/10/2008SE |
| K050425 | Aura-PsgOLV · Traditional | Astro-Med, Inc. | 10/20/2005SE |
| K052066 | Ceegraph/Sleepscan Netlink TravelerOLV · Special | Bio-Logic Systems Corp. | 08/26/2005SE |
| K050833 | Electrode Junction Box, Model JE-921AOLV · Special | Nihon Kohden America, Inc. | 04/29/2005SE |
| K050143 | Omnipro SystemOLV · Traditional | Mays and Associates, Inc. | 02/01/2005SE |
| K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120OLV · Traditional | Cleveland Medical Devices, Inc. | 11/17/2004SE |
| K042364 | Panbus Digital EEG & Sleep Acquisition DevicesOLV · Special | Lamont Medical, Inc. | 09/30/2004SE |
| K033475 | Wireless Input Unit, Model WEE-1000A SeriesOLV · Traditional | Nihon Kohden America, Inc. | 01/07/2004SE |
| K031202 | MEDIPALM-20OLV · Traditional | Braebon Medical Corp. | 05/01/2003SE |
| K022249 | Nightron Polysomnography SystemOLV · Traditional | Telediagnostic Systems, Inc. | 12/31/2002SE |
| K022037 | Xltek Sleep SystemOLV · Special | Excel Tech. , Ltd. | 09/10/2002SE |
| K021807 | Grass-Telefactor AS40 Amplifier SystemOLV · Traditional | Grass Instrument Co. | 08/29/2002SE |
| K022121 | PSG Input Box, Model JE-912AKOLV · Special | Nihon Kohden America, Inc. | 07/29/2002SE |
| K021185 | Nervus MonitorOLV · Traditional | Taugagreining HF | 07/12/2002SE |
| K012976 | Twin PlusOLV · Traditional | Grass-Telefactor Divison | 02/12/2002SE |
| K013450 | Notta Ambulatory RecorderOLV · Abbreviated | Stellate Systems | 01/14/2002SE |
| K012085 | Somno Star & Series Sleep SystemOLV · Special | Sensor Medics Corp. | 08/02/2001SE |
| K010728 | Harmone-Schwarzer EEG SystemOLV · Abbreviated | Stellate Systems | 05/21/2001SE |
| K010460 | Lifelines TrackitOLV · Traditional | Lifelines , Ltd. | 05/14/2001SE |
| K011204 | Neurofax, Models EEG-1100A, EEG-9100AOLV · Special | Nihon Kohden America, Inc. | 05/08/2001SE |
| K003175 | Compumedics Siesta SystemOLV · Traditional | Compumedics Limited | 12/27/2000SE |
| K003681 | Bio-Logic Sleepscan NetlinkOLV · Special | Bio-Logic Systems Corp. | 12/21/2000SE |
| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | Airsep Corp. | 05/16/2000SE |
| K000338 | Vitaport 3OLV · Traditional | Nihon Kohden America, Inc. | 04/26/2000SE |
| K994142 | Grass TS3201/6401 EEG Amplifier SystemOLV · Traditional | Grass Instrument Co. | 03/06/2000SE |
| K992742 | Neurofax, Model EEG-1100AOLV · Traditional | Nihon Kohden America, Inc. | 10/14/1999SE |
| K992283 | Artisan Acquisition System for EEG and PolysomnographyOLV · Traditional | Airsep Corp. | 08/27/1999SE |
| K992291 | H20- Tethered OptionOLV · Special | Grass-Telefactor Product Group | 08/06/1999SE |
| K991446 | Biosaca System, Model 800OLV · Traditional | Biosys AB (Publ) | 07/23/1999SE |
| K991900 | Xltek Polysomnography Headbox, Model # PSG-40OLV · Traditional | Excel Tech. , Ltd. | 07/12/1999SE |
| K990522 | Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse…OLV · Traditional | Lamont Medical, Inc. | 05/19/1999SE |
| K984580 | Biosaca SystemOLV · Traditional | Biosys AB (Publ) | 03/12/1999SE |
| K983072 | Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201OLV · Traditional | Nihon Kohden America, Inc. | 12/01/1998SE |
| K983913 | Modification to Bio-Logic SleepscanOLV · Special | Bio-Logic Systems Corp. | 11/25/1998SE |
| K974583 | DeegliteOLV · Traditional | Grass-Telefactor Product Group | 06/09/1998SE |
| K974587 | H2OOLV · Traditional | Grass-Telefactor Product Group | 03/09/1998SE |
| K971813 | EmblaOLV · Traditional | Ferguson Medical | 01/16/1998SE |
| K971867 | Alice 4R SystemOLV · Traditional | Healthdyne Technologies, Inc. | 08/13/1997SE |
| K970951 | Grass Brainwave SoftwareOLV · Traditional | Astro-Med, Inc. | 05/19/1997SE |
| K961638 | Medilog Mpa-SOLV · Traditional | Oxford Instruments Medical Systems | 01/17/1997SE |
| K922106 | AliceOLV · Traditional | Healthdyne, Inc. | 07/06/1994SE |
| K934599 | SandmanOLV · Traditional | Melville Software , Ltd. | 01/27/1994SE |
| K860458 | Electrophysiological System to Monitor Skin Temp.OLV · Traditional | Oxford Medilog, Inc. | 08/12/1986SE |
| K854665 | 4312P Polysomnograph ElectoenciphalographOLV · Traditional | Nihon Kohden America, Inc. | 06/05/1986SE |
| K860219 | Sasssy Semi Automatic Sleep Scoring SystemOLV · Traditional | Grass-Telefactor Product Group | 04/17/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2568-2018 Class II | Nicolet Ambulatory EEGPotential to be able to import an ambulatory exam for a patient for which the exam was not started. | Natus Neurology Inc | 02/01/2018Terminated |