510(k) K974211 ยท ESD Hearing Aid, Air-Conduction, Prescription
OPUS 2 - FULL CONCHA SERIES - ITE
| Applicant | Bernafon-Maico, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Dec 15, 1997 |
| Received | Nov 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974211
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.