510(k) K935366 ยท ESD Hearing Aid, Air-Conduction, Prescription
BINAURAL HEARING AID
| Applicant | Telex Communications, Inc., Lincoln NE, US |
| Decision | Substantially Equivalent, Jan 13, 1994 |
| Received | Nov 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935366
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.