510(k) K251208 ยท SCR Air-Conduction Hearing Aid Software
Tuned Self-Fitting Mobile App
| Applicant | Tuned , Ltd., Gan Yoshiya, IL |
| Decision | Substantially Equivalent, Sep 26, 2025 |
| Received | Apr 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251208
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.