510(k) K000184 ยท EWO Audiometer
AUDIOSCREENER OAE
| Applicant | Kedly, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 11, 2000 |
| Received | Jan 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000184
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.