510(k) K972345 ยท ESD Hearing Aid, Air-Conduction, Prescription
DAHLBERG/MIRACLE-EAR
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | Jun 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972345
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.