510(k) K983352 ยท EWO Audiometer
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
| Applicant | Otodynamics, Ltd., Crofton MD, US |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Sep 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983352
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.