510(k) K010165 ยท EWO Audiometer
ERO SCAN OAE TEST SYSTEM
| Applicant | Etymotic Research, Elk Grove Village IL, US |
| Decision | Substantially Equivalent, Mar 12, 2001 |
| Received | Jan 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010165
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.