510(k) K903143 ยท EWO Audiometer
OTOSCREENER-I AND OTO-SCREEN-I-P
| Applicant | Handtronix, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Sep 19, 1990 |
| Received | Jul 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903143
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.