510(k) K973320 ยท EWO Audiometer
ARTICULATE FITTING SYSTEM
| Applicant | Decibel Instruments, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Nov 25, 1997 |
| Received | Sep 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973320
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.