510(k) K861492 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARING AID (ALL IN THE EAR)
| Applicant | Crystal Tone Hearing Instruments, Des Moines IA, US |
| Decision | Substantially Equivalent, May 2, 1986 |
| Received | Apr 22, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861492
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.