GWL — Amplifier, Physiological Signal Class II
FDA Device Classification
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 |