K260566
- 510(k) number
- K260566
- Device name
- SMARTVERTIGO Vestibular Assessment System
- Applicant
- VertigoDx, Inc. DE · US
- Product code
- GWN — Nystagmograph
- Decision date
- 2026-07-30
- Date received
- 2026-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K260566.pdf
Official FDA record: K260566
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.