510(k) K897035 ยท ESD Hearing Aid, Air-Conduction, Prescription
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, May 23, 1990 |
| Received | Dec 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897035
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.