K240430
- 510(k) number
- K240430
- Device name
- Otoport Pro
- Applicant
- Otodynamics, Ltd. GB
- Product code
- EWO — Audiometer
- Decision date
- 2024-03-15
- Date received
- 2024-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240430.pdf
Official FDA record: K240430
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.