GWQ
- Product code
- GWQ
- Device name
- Full-Montage Standard Electroencephalograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 189 (all years; only the last 3 years are listed here)
FDA classification definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261604 | 2026-06-13 | Neuroelectrics Barcelona S.L.U. | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Eno | |
| K260455 | 2026-03-13 | Zeto, Inc. | New Wave System | |
| K233403 | 2024-04-30 | Zeto, Inc. | Flexset System | |
| K231366 | 2023-11-09 | Bioserenity Sas | Neuronaute Plus |
Official FDA classification page: GWQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).