510(k) K964669 ยท ESD Hearing Aid, Air-Conduction, Prescription
MIRACLE-EAR OR AUDIOTONE
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Dec 26, 1996 |
| Received | Nov 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964669
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.