510(k) K864097 ยท ESD Hearing Aid, Air-Conduction, Prescription
WIDEX HEARING AID MODEL ES2
| Applicant | Widex Hearing Aid Co., Inc., Long Island City NY, US |
| Decision | Substantially Equivalent, Nov 5, 1986 |
| Received | Oct 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864097
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.