510(k) K962228 ยท ESD Hearing Aid, Air-Conduction, Prescription
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
| Applicant | Ototech Intl., Inc., Oklahoma City OK, US |
| Decision | Substantially Equivalent, Aug 28, 1996 |
| Received | Jun 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962228
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.