510(k) K964680 ยท ESD Hearing Aid, Air-Conduction, Prescription
COMFORTAID HEARING AID
| Applicant | Ethical Hearing Instruments, Portsmouth NH, US |
| Decision | Substantially Equivalent, Jan 24, 1997 |
| Received | Nov 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964680
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.