510(k) K003558 ยท ESD Hearing Aid, Air-Conduction, Prescription
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
| Applicant | Siemens Hearing Instruments, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Apr 24, 2001 |
| Received | Nov 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003558
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.