510(k) K941295 ยท ESD Hearing Aid, Air-Conduction, Prescription
SHARP II HELIX HEARING AID
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Jun 17, 1994 |
| Received | Mar 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941295
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.