510(k) K900197 ยท EWO Audiometer
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
| Applicant | Sound Linked Data, Inc., Canada L4w 2tf, CA |
| Decision | Substantially Equivalent, Apr 17, 1991 |
| Received | Jan 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900197
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.