510(k) K964216 ยท KLW Masker, Tinnitus
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
| Applicant | Starkey Laboratories, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Dec 6, 1996 |
| Received | Oct 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964216
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.