K234095
- 510(k) number
- K234095
- Device name
- OtoNova/OtoNova Pro
- Applicant
- Otodynamics GB
- Product code
- EWO — Audiometer
- Decision date
- 2024-06-21
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 3.5 MB · U.S. public domain
Also available from FDA: K234095.pdf
Official FDA record: K234095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.