510(k) K964419 ยท ESD Hearing Aid, Air-Conduction, Prescription
MIRACLE - EAR (ITE/ITC/CIC)
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Oct 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964419
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.