510(k) K910097 ยท ESD Hearing Aid, Air-Conduction, Prescription
ELECTONE ITE MODEL PREMIER
| Applicant | Electone, Inc., Winter Park FL, US |
| Decision | Substantially Equivalent, Apr 3, 1991 |
| Received | Jan 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910097
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.