GWL
- Product code
- GWL
- Device name
- Amplifier, Physiological Signal
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1835
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 53 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243746 | 2025-03-12 | Quantalx Neroscience | Delphi Amplifier | |
| K242832 | 2024-12-12 | Eb Neuro S.P.A. | NExT Station; NExT Station Advanced | |
| K240646 | 2024-09-04 | Somnomed Technologies Inc., Doing Busi… | DreamClear | |
| K242305 | 2024-09-04 | Eb Neuro S.P.A. | BE Plus PRO, Neurotravel LIGHT | |
| K232210 | 2024-02-04 | X-Trodes | X-trodes System M | |
| K230148 | 2023-10-11 | Dormotech Medical, Ltd. | Vlab |
Official FDA classification page: GWL
Classification and pathway per current FDA publications. Data from openFDA (CC0).