510(k) K942523 ยท ESD Hearing Aid, Air-Conduction, Prescription
MIRACLE-EAR IMPRESSION MATERIAL KIT
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Sep 23, 1994 |
| Received | Apr 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942523
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.