Product code GWL
- Device name
- Amplifier, Physiological Signal
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1835
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243746 | Delphi Amplifier | Quantalx Neroscience | 2025-03-12 |
| K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024-12-12 |
| K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | 2024-09-04 |
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | 2024-09-04 |
| K232210 | X-trodes System M | X-Trodes | 2024-02-04 |
| K230148 | Vlab | Dormotech Medical, Ltd. | 2023-10-11 |
| K223676 | SomniCheck | Brainmatterz, LLC | 2023-06-01 |
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022-07-15 |
| K203331 | Quick-20m | Cgx, LLC | 2021-05-20 |
| K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | 2021-02-10 |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020-12-27 |
| K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | 2018-03-30 |
| K171397 | Sienna Ultimate Wireless Amplifier | Ems Handels Gesellschaft M.B.H. | 2017-10-06 |
| K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017-07-05 |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | 2015-10-23 |
| K133517 | NEMUS 2 SYSTEM | Eb Neuro S.P.A. | 2014-02-26 |
| K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012-12-20 |
| K121996 | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | Eb Neuro S.P.A. | 2012-08-03 |
| K103140 | NICOLET WIRELESS EEG | Carefusion 209, Inc. | 2011-04-08 |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Neurotronics, Inc. | 2010-03-18 |
| K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM | I2s Micro Implantable Systems, LLC | 2009-05-28 |
| K083322 | NEUROMETRIX BIOAMPLIFIER | Neurometrix, Inc. | 2009-05-27 |
| K063599 | PORTI 7 PHYSIOLOGICAL AMPLIFIER | Tms International BV | 2007-03-22 |
| K060374 | REFA, PHYSIOLOGICAL AMPLIFIER | Tms International BV | 2006-05-30 |
| K060803 | G.USBAMP | G.Tec Medical Engineering GmbH | 2006-05-02 |
| K053606 | BE PLUS / AURA-LTM64 AMPLIFIER | Eb Neuro S.P.A. | 2006-01-24 |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | Allergan, Inc. | 2005-09-14 |
| K052060 | OPTI-AMP DC-POWERED | Intelligent Hearing Systems | 2005-08-31 |
| K041198 | NIC36 AMPLIFIER | Eb Neuro S.P.A. | 2004-06-01 |
| K040113 | SANDMAN SD20 AMPLIFIER | Eb Neuro S.P.A. | 2004-02-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446900338 | NeMus 2 600 | EB NEURO SPA | 2025-05-26 |
| 08056446900345 | NeMus 2 700 | EB NEURO SPA | 2025-05-26 |
| 08056446900352 | NeMus 2 + | EB NEURO SPA | 2025-05-26 |
| 08056446901205 | NExT Station | EB NEURO SPA | 2025-05-22 |
| 08056446901199 | NExT-AS | EB NEURO SPA | 2025-05-22 |
| 08056446901168 | NExT-AMP | EB NEURO SPA | 2025-05-22 |
| 08056446901137 | NExT-HS | EB NEURO SPA | 2025-05-22 |
| 08056446901120 | NExT-AMP-ADVANCED | EB NEURO SPA | 2025-05-22 |
| 08056446901113 | NExT-PAD | EB NEURO SPA | 2025-05-22 |
| 08056446901106 | NExT-DOCKING | EB NEURO SPA | 2025-05-22 |
| 18436612823048 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-14 |
| 18436612823031 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-14 |
| 18436612823000 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-13 |
| 18436612823017 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-13 |
| 18436612823024 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-13 |
| 18436612820269 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-06 |
| 18436612820276 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-06 |
| 18436612820283 | Enobio Dx | NEUROELECTRICS BARCELONA SL | 2023-09-06 |
| 08437017440796 | ENOBIO | NEUROELECTRICS BARCELONA SL | 2019-06-21 |
| 08056446900376 | NeMus 2 | EB NEURO SPA | 2019-04-10 |
| 08056446900369 | NeMus 2 | EB NEURO SPA | 2019-04-10 |
| 08056446900949 | BE Micro 21 CH MONO PLUG-IN HEADBOX | EB NEURO SPA | 2019-04-02 |
| 08056446900055 | BE Micro Headbox | EB NEURO SPA | 2019-04-02 |
| 08056446900048 | BE Micro PLUG-IN HEADBOX | EB NEURO SPA | 2019-04-02 |
| 08056446900024 | BE Micro USB BRIDGE | EB NEURO SPA | 2019-04-02 |
| 08056446900956 | BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL | EB NEURO SPA | 2019-04-02 |
| 08056446900017 | BE Micro Recorder | EB NEURO SPA | 2019-04-02 |
| 08056446900000 | BE Micro | EB NEURO SPA | 2019-04-01 |
| 08719481170028 | TMSi | TMSi | 2017-12-16 |
| 08719481170011 | TMSi | TMSi | 2017-10-13 |