510(k) K910313 ยท ESD Hearing Aid, Air-Conduction, Prescription
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
| Applicant | Ototech, Ltd., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 18, 1991 |
| Received | Jan 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910313
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.