510(k) K913771 ยท ESD Hearing Aid, Air-Conduction, Prescription
ELEGANCE - KED, BEHIND THE EAR HEARING AID
| Applicant | Qualitone, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 18, 1991 |
| Received | Aug 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913771
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.