510(k) K980505 ยท EWO Audiometer
HORTMANN AMDIS-OAE OAE ANALYZER
| Applicant | Hortmann AG, Dripping Springs TX, US |
| Decision | Substantially Equivalent, Apr 7, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980505
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.