510(k) K963915 ยท ESD Hearing Aid, Air-Conduction, Prescription
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
| Applicant | Telex Communications, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 8, 1996 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963915
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.