510(k) K011364 ยท KLW Masker, Tinnitus
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
| Applicant | Siemens Hearing Instruments, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Jun 7, 2001 |
| Received | May 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011364
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.