510(k) K831197 ยท ESD Hearing Aid, Air-Conduction, Prescription
MODEL 343D HEARING AID
| Applicant | Telex Communications, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 9, 1983 |
| Received | Apr 12, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831197
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.