510(k) K945199 ยท EWO Audiometer
RH2000 REAL EAR MEASUREMENT SYSTEM
| Applicant | Madsen Electronics, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 11, 1995 |
| Received | Oct 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945199
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.