510(k) K934416 ยท ESD Hearing Aid, Air-Conduction, Prescription
OMNI 2000 SERIES ITE HEARING AID
| Applicant | Starkey Laboratories, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Nov 29, 1993 |
| Received | Sep 13, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934416
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.