510(k) K964639 ยท ESD Hearing Aid, Air-Conduction, Prescription
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
| Applicant | Telex Communications, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 21, 1997 |
| Received | Nov 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964639
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.