K221052
- 510(k) number
- K221052
- Device name
- Self-Fitting hearing aids
- Applicant
- Huizhou Jinghao Medical Technology Co., Ltd. CN
- Product code
- QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Co
- Decision date
- 2023-09-25
- Date received
- 2022-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K221052.pdf
Official FDA record: K221052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.