510(k) K864277 ยท ESD Hearing Aid, Air-Conduction, Prescription
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
| Applicant | Unimax Hearing Instruments, Denton TX, US |
| Decision | Substantially Equivalent, Jan 9, 1987 |
| Received | Oct 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864277
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.