510(k) K894428 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARING AID (IN-THE-EAR)
| Applicant | Hearing Aid Express, Dallas TX, US |
| Decision | Substantially Equivalent, Oct 24, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894428
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.