Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1835](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1835) → GWL — Amplifier, Physiological Signal # GWL · Amplifier, Physiological Signal _Neurology · 21 CFR 882.1835 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL ## Overview - **Product Code:** GWL - **Device Name:** Amplifier, Physiological Signal - **Regulation:** [21 CFR 882.1835](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1835) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K243746.md) | Delphi Amplifier | Quantalx Neroscience | Mar 12, 2025 | SESE | | [K242832](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K242832.md) | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | Dec 12, 2024 | SESE | | [K242305](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K242305.md) | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | Sep 4, 2024 | SESE | | [K240646](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K240646.md) | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | Sep 4, 2024 | SESE | | [K232210](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K232210.md) | X-trodes System M | X-Trodes | Feb 4, 2024 | SESE | | [K230148](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K230148.md) | Vlab | Dormotech Medical, Ltd. | Oct 11, 2023 | SESE | | [K223676](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K223676.md) | SomniCheck | Brainmatterz, LLC | Jun 1, 2023 | SESE | | [K220631](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K220631.md) | NomadAir PMU810 | Neurotronics, Inc. | Jul 15, 2022 | SESE | | [K203331](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K203331.md) | Quick-20m | Cgx, LLC | May 20, 2021 | SESE | | [K202174](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K202174.md) | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | Feb 10, 2021 | SESE | | [K201747](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K201747.md) | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | Dec 27, 2020 | SESE | | [K172312](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K172312.md) | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | Mar 30, 2018 | SESE | | [K171397](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K171397.md) | Sienna Ultimate Wireless Amplifier | Ems Handels Gesellschaft M.B.H. | Oct 6, 2017 | SESE | | [K171669](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K171669.md) | g.Nautilus PRO | G.Tec Medical Engineering GmbH | Jul 5, 2017 | SESE | | [K151600](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K151600.md) | R-40 EEG Amplifier | Lifelines , Ltd. | Oct 23, 2015 | SESE | | [K133517](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K133517.md) | NEMUS 2 SYSTEM | Eb Neuro S.P.A. | Feb 26, 2014 | SESE | | [K123255](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K123255.md) | g.HIamp | G.Tec Medical Engineering GmbH | Dec 20, 2012 | SESE | | [K121996](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K121996.md) | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | Eb Neuro S.P.A. | Aug 3, 2012 | SESE | | [K103140](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K103140.md) | NICOLET WIRELESS EEG | Carefusion 209, Inc. | Apr 8, 2011 | SESE | | [K092699](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K092699.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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