510(k) K894176 ยท ESD Hearing Aid, Air-Conduction, Prescription
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
| Applicant | Precision Hearing Instruments, Rocky Point NY, US |
| Decision | Substantially Equivalent, Nov 3, 1989 |
| Received | Jun 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894176
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.