Amplifier, Physiological Signal
FDA product code GWL · Class II (moderate risk) · 21 CFR 882.1835 · Neurology
53510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Eb Neuro S.P.A. 8
- G.Tec Medical Engineering GmbH 3
- Nihon Kohden America, Inc. 3
- Tms International BV 2
- Neurotronics, Inc. 2
- Intelligent Hearing Systems 2
- Honeywell, Inc. 2
- Amplus Corp. 1
- Astro-Med, Inc. 1
- Cns, Inc. 1
- Micro Tronics Corp. 1
- Telediagnostic Systems, Inc. 1
- Bio-Feedback Systems, Inc. 1
- Neuroscientific Corp. 1
- Nicolet Biomedical Instruments 1
- Professional Health Technologies, Inc. 1
- Quantalx Neroscience 1
- Rc Electronics, Inc. 1
- Metraco, Inc. 1
- Tracor Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243746 | Delphi AmplifierGWL · Traditional | Quantalx Neroscience | 03/12/2025SE |
| K242832 | NExT Station; NExT Station AdvancedGWL · Special | Eb Neuro S.P.A. | 12/12/2024SE |
| K242305 | BE Plus PRO, Neurotravel LIGHTGWL · Special | Eb Neuro S.P.A. | 09/04/2024SE |
| K240646 | DreamClearGWL · Traditional | Somnomed Technologies Inc., Doing Business AS… | 09/04/2024SE |
| K232210 | X-trodes System MGWL · Traditional | X-Trodes | 02/04/2024SE |
| K230148 | VlabGWL · Traditional | Dormotech Medical, Ltd. | 10/11/2023SE |
| K223676 | SomniCheckGWL · Traditional | Brainmatterz, LLC | 06/01/2023SE |
| K220631 | NomadAir PMU810GWL · Traditional | Neurotronics, Inc. | 07/15/2022SE |
| K203331 | Quick-20mGWL · Traditional | Cgx, LLC | 05/20/2021SE |
| K202174 | Digital NeuroPort Biopotential Signal Processing SystemGWL · Special | Blackrock Microsystems | 02/10/2021SE |
| K201747 | 8-CH Electroencephalography AmplifierGWL · Traditional | Hipposcreen Neurotech Corp. | 12/27/2020SE |
| K172312 | eego amplifiersGWL · Traditional | Eemagine Medical Imaging Solutions GmbH | 03/30/2018SE |
| K171397 | Sienna Ultimate Wireless AmplifierGWL · Traditional | Ems Handels Gesellschaft M.B.H. | 10/06/2017SE |
| K171669 | g.Nautilus PROGWL · Traditional | G.Tec Medical Engineering GmbH | 07/05/2017SE |
| K151600 | R-40 EEG AmplifierGWL · Traditional | Lifelines , Ltd. | 10/23/2015SE |
| K133517 | Nemus 2 SystemGWL · Traditional | Eb Neuro S.P.A. | 02/26/2014SE |
| K123255 | g.HIampGWL · Traditional | G.Tec Medical Engineering GmbH | 12/20/2012SE |
| K121996 | Be Plus LTM Amplifier Gwi AmplifierGWL · Special | Eb Neuro S.P.A. | 08/03/2012SE |
| K103140 | Nicolet Wireless EEGGWL · Traditional | Carefusion 209, Inc. | 04/08/2011SE |
| K092699 | Nomad Sleep System Recorder, Model PMU800GWL · Traditional | Neurotronics, Inc. | 03/18/2010SE |
| K090957 | Blackrock Neuroport Biopotential Signal Processing SystemGWL · Abbreviated | I2s Micro Implantable Systems, LLC | 05/28/2009SE |
| K083322 | Neurometrix BioamplifierGWL · Traditional | Neurometrix, Inc. | 05/27/2009SE |
| K063599 | Porti 7 Physiological AmplifierGWL · Special | Tms International BV | 03/22/2007SE |
| K060374 | Refa, Physiological AmplifierGWL · Abbreviated | Tms International BV | 05/30/2006SE |
| K060803 | G.UsbampGWL · Traditional | G.Tec Medical Engineering GmbH | 05/02/2006SE |
| K053606 | Be Plus / AURA-LTM64 AmplifierGWL · Special | Eb Neuro S.P.A. | 01/24/2006SE |
| K051852 | Single Amplifier for BotoxGWL · Traditional | Allergan, Inc. | 09/14/2005SE |
| K052060 | Opti-Amp Dc-PoweredGWL · Special | Intelligent Hearing Systems | 08/31/2005SE |
| K041198 | NIC36 AmplifierGWL · Special | Eb Neuro S.P.A. | 06/01/2004SE |
| K040113 | Sandman SD20 AmplifierGWL · Special | Eb Neuro S.P.A. | 02/18/2004SE |
| K003154 | Mizar, Basis Be, Sandman DigitalGWL · Traditional | Eb Neuro S.P.A. | 01/05/2001SE |
| K972515 | Sensor AmplifierGWL · Traditional | Pro-Tech Services, Inc. | 10/02/1997SE |
| K963669 | Grass Model 15 Neurodata Amplifier SystemGWL · Traditional | Astro-Med, Inc. | 12/12/1996SE |
| K943673 | MMC AmplifierGWL · Traditional | Melville Software , Ltd. | 10/26/1994SE |
| K914876 | Opti-AmpGWL · Traditional | Intelligent Hearing Systems | 01/10/1992SE |
| K912436 | Am-PakGWL · Traditional | Cns, Inc. | 10/18/1991SE |
| K901797 | The Wonder BoxGWL · Traditional | Micro Tronics Corp. | 02/07/1991SE |
| K904222 | Vista Graph Polysomnography AmplifierGWL · Traditional | Telediagnostic Systems, Inc. | 01/18/1991SE |
| K900063 | Multi-Channel Isolation Amplifier (Mcia)GWL · Traditional | Bio-Feedback Systems, Inc. | 02/16/1990SE |
| K884071 | Amplaid EMG15GWL · Traditional | Amplus Corp. | 02/27/1989SE |
| K881177 | Model MEB-5304 Evoked Potential & Electro. RecordGWL · Traditional | Nihon Kohden America, Inc. | 09/30/1988SE |
| K880773 | The Venus SystemGWL · Traditional | Neuroscientific Corp. | 08/18/1988SE |
| K870794 | MEM-4104 Evoked Response/Electromyography RecorderGWL · Traditional | Nihon Kohden America, Inc. | 09/30/1987SE |
| K871678 | Nicolet Amp 6R11 SystemGWL · Traditional | Nicolet Biomedical Instruments | 07/16/1987SE |
| K860289 | PHD-36 Physiological Signal AmplifierGWL · Traditional | Professional Health Technologies, Inc. | 08/25/1986SE |
| K861014 | Amplaid MK15 (Evoked Potential System)GWL · Traditional | Amplaid USA, Inc. | 08/20/1986SE |
| K841612 | Neuropack II 5100GWL · Traditional | Nihon Kohden America, Inc. | 06/07/1984SE |
| K833413 | Computerscope Cps-AbrGWL · Traditional | Rc Electronics, Inc. | 11/28/1983SE |
| K821250 | Metraco Evoked Potential SystemGWL · Traditional | Metraco, Inc. | 07/02/1982SE |
| K781743 | Response System, TN-3000GWL · Traditional | Tracor Instruments, Inc. | 12/01/1978SE |
| K781289 | Preamplifier Model 113GWL · Traditional | Princeton Applied Research Corp. | 09/14/1978SE |
| K772102 | Amplifier Otrona, Model N3A-EMGGWL · Traditional | Honeywell, Inc. | 11/21/1977SE |
| K771683 | Amplifier Model N3B-EEGGWL · Traditional | Honeywell, Inc. | 09/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2764-2016 Class II | Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within…Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential… | Blackrock Microsystems, LLC | 08/10/2016Terminated |
| Z-2763-2016 Class II | Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The…Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential… | Blackrock Microsystems, LLC | 08/10/2016Terminated |
| Z-0946-2013 Class II | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the…Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become… | Natus Neurology Incorporated | 02/27/2013Terminated |
| Z-1619-2010 | Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake…Component of cranial array may not allow sufficient tightening to maintain inserter position. | I2s Micro Implantable Systems Llc | 03/26/2010Terminated |