K251208
- 510(k) number
- K251208
- Device name
- Tuned Self-Fitting Mobile App
- Applicant
- Tuned , Ltd. IL
- Product code
- SCR — Air-Conduction Hearing Aid Software
- Decision date
- 2025-09-26
- Date received
- 2025-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251208.pdf
Official FDA record: K251208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.