510(k) K954528 ยท ESD Hearing Aid, Air-Conduction, Prescription
MIRACLE - EAR MODEL PBP
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Oct 7, 1995 |
| Received | Sep 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954528
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.