510(k) K964340 ยท EWO Audiometer
PORTAREM-3000, PFS-6000
| Applicant | Starkey Laboratories, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Oct 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964340
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.