510(k) K003913 ยท EWO Audiometer
HINT AUDIOMETER, OR HINT
| Applicant | Maico-Diagnostics, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 16, 2001 |
| Received | Dec 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003913
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.