GWL — Amplifier, Physiological Signal Class II
FDA product code GWL covers "Amplifier, Physiological Signal", a Class II medical device regulated under 21 CFR 882.1835. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWL
- Device Class
- Class II
- Regulation Number
- 882.1835
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243746 | quantalx neroscience | Delphi Amplifier | March 12, 2025 |
| K242832 | eb neuro | NExT Station; NExT Station Advanced | December 12, 2024 |
| K242305 | eb neuro | BE Plus PRO, Neurotravel LIGHT | September 4, 2024 |
| K240646 | somnomed technologies inc., doing business as remware | DreamClear | September 4, 2024 |
| K232210 | x-trodes | X-trodes System M | February 4, 2024 |
| K230148 | dormotech medical | Vlab | October 11, 2023 |
| K223676 | brainmatterz | SomniCheck | June 1, 2023 |
| K220631 | neurotronics | NomadAir PMU810 | July 15, 2022 |
| K203331 | cgx | Quick-20m | May 20, 2021 |
| K202174 | blackrock microsystems | Digital NeuroPort Biopotential Signal Processing System | February 10, 2021 |
| K201747 | hipposcreen neurotech | 8-CH Electroencephalography Amplifier | December 27, 2020 |
| K172312 | eemagine medical imaging solutions | eego amplifiers | March 30, 2018 |
| K171397 | ems handels gesellschaft m.b.h | Sienna Ultimate Wireless Amplifier | October 6, 2017 |
| K171669 | g.tec medical engineering | g.Nautilus PRO | July 5, 2017 |
| K151600 | lifelines | R-40 EEG Amplifier | October 23, 2015 |
| K133517 | eb neuro | NEMUS 2 SYSTEM | February 26, 2014 |
| K123255 | g.tec medical engineering | g.HIamp | December 20, 2012 |
| K121996 | eb neuro | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | August 3, 2012 |
| K103140 | carefusion 209 | NICOLET WIRELESS EEG | April 8, 2011 |
| K092699 | neurotronics | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | March 18, 2010 |