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)
- 4
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 60 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260566 | 2026-07-30 | VertigoDx, Inc. | SMARTVERTIGO Vestibular Assessment System | FDA |
| K243709 | 2025-08-25 | Neuroears, Inc. | NeuroEars-Anna | |
| K242198 | 2025-02-14 | Natus Medical Denmark Aps | ICS Dizcovery (1091) | |
| K242726 | 2025-01-03 | Inventis S.R.L. | Synapsys VHIT | FDA |
Official FDA classification page: GWN
Classification and pathway per current FDA publications. Data from openFDA (CC0).