GWN
- Product code
- GWN
- Device name
- Nystagmograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1460
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 60
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K260566 | 2026-07-30 | VertigoDx, Inc. | SMARTVERTIGO Vestibular Assessment System summary |
| K243709 | 2025-08-25 | Neuroears, Inc. | NeuroEars-Anna summary |
| K242198 | 2025-02-14 | Natus Medical Denmark Aps | ICS Dizcovery (1091) summary |
| K242726 | 2025-01-03 | Inventis S.R.L. | Synapsys VHIT summary |
Official FDA classification page: GWN
Classification and pathway per current FDA publications. Data from openFDA (CC0).