510(k) K921085 ยท EWO Audiometer
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
| Applicant | Hear-Well Technologies, Inc., Guelph, CA |
| Decision | Substantially Equivalent, May 15, 1992 |
| Received | Mar 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921085
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.