K231545
- 510(k) number
- K231545
- Device name
- hearOAE
- Applicant
- Hearx SA (Pty) , Ltd. ZA
- Product code
- EWO — Audiometer
- Decision date
- 2023-10-27
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231545.pdf
Official FDA record: K231545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.