510(k) K913356 ยท EWO Audiometer
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
| Applicant | Monitor Instruments, Inc., Chapel Hill NC, US |
| Decision | Substantially Equivalent, Dec 5, 1991 |
| Received | Jul 30, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913356
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.