GWL · Amplifier, Physiological Signal
Neurology · 21 CFR 882.1835 · Class 2
Overview
| Product Code | GWL |
|---|---|
| Device Name | Amplifier, Physiological Signal |
| Regulation | 21 CFR 882.1835 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243746 | Delphi Amplifier | Quantalx Neroscience | Mar 12, 2025 | SESE |
| K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | Dec 12, 2024 | SESE |
| K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | Sep 4, 2024 | SESE |
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | Sep 4, 2024 | SESE |
| K232210 | X-trodes System M | X-Trodes | Feb 4, 2024 | SESE |
| K230148 | Vlab | Dormotech Medical, Ltd. | Oct 11, 2023 | SESE |
| K223676 | SomniCheck | Brainmatterz, LLC | Jun 1, 2023 | SESE |
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | Jul 15, 2022 | SESE |
| K203331 | Quick-20m | Cgx, LLC | May 20, 2021 | SESE |
| K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | Feb 10, 2021 | SESE |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | Dec 27, 2020 | SESE |
| K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | Mar 30, 2018 | SESE |
| K171397 | Sienna Ultimate Wireless Amplifier | Ems Handels Gesellschaft M.B.H. | Oct 6, 2017 | SESE |
| K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | Jul 5, 2017 | SESE |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | Oct 23, 2015 | SESE |
| K133517 | NEMUS 2 SYSTEM | Eb Neuro S.P.A. | Feb 26, 2014 | SESE |
| K123255 | g.HIamp | G.Tec Medical Engineering GmbH | Dec 20, 2012 | SESE |
| K121996 | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | Eb Neuro S.P.A. | Aug 3, 2012 | SESE |
| K103140 | NICOLET WIRELESS EEG | Carefusion 209, Inc. | Apr 8, 2011 | SESE |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Neurotronics, Inc. | Mar 18, 2010 | SESE |
Top Applicants
- Eb Neuro S.P.A. — 8 clearances
- G.Tec Medical Engineering GmbH — 3 clearances
- Nihon Kohden America, Inc. — 3 clearances
- Honeywell, Inc. — 2 clearances
- Intelligent Hearing Systems — 2 clearances
