510(k) K964426 ยท EWO Audiometer
SMARTOAE
| Applicant | Intelligent Hearing Systems, North Miami FL, US |
| Decision | Substantially Equivalent, Feb 3, 1997 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964426
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.