K233747
- 510(k) number
- K233747
- Device name
- Concha Sol Hearing Aids (CL-1001)
- Applicant
- Concha Labs CA · US
- Product code
- QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Co
- Decision date
- 2024-03-15
- Date received
- 2023-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233747.pdf
Official FDA record: K233747
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.