510(k) K061104 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
SPEECHLINK 100 TYPE 1053
| Applicant | Gn Otometrics A/S, Taastrup, DK |
| Decision | Substantially Equivalent, May 3, 2006 |
| Received | Apr 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061104
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.