510(k) K972221 ยท EWO Audiometer
K 15 AUDIOMETER
| Applicant | American Electromedics Corp., Amherst NH, US |
| Decision | Substantially Equivalent, Sep 8, 1997 |
| Received | Jun 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972221
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.