510(k) K883169 ยท EWO Audiometer
OTOMETER PORTABLE SCREENING AUDIOMETER
| Applicant | Otometer, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Dec 7, 1988 |
| Received | Jul 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883169
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.