510(k) K911497 ยท ESD Hearing Aid, Air-Conduction, Prescription
CUSTOM PERSONAL EAR - CPE
| Applicant | Qualitone, Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 19, 1991 |
| Received | Apr 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911497
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.