510(k) K961084 ยท ESD Hearing Aid, Air-Conduction, Prescription
AM 400
| Applicant | Electone, Inc., Longwood FL, US |
| Decision | Substantially Equivalent, Apr 18, 1996 |
| Received | Mar 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961084
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.