K233464
- 510(k) number
- K233464
- Device name
- WSA Self-Fitting Hearing Aid Gen 2
- Applicant
- Wsaud A/S DK
- Product code
- QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Co
- Decision date
- 2024-02-09
- Date received
- 2023-10-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233464.pdf
Official FDA record: K233464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.