510(k) K943961 ยท ESD Hearing Aid, Air-Conduction, Prescription
THE MODEL ACAPPELLA IN THE EAR HEARING AID
| Applicant | Telex Communications, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Aug 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943961
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.