510(k) K033645 ยท ETY Tester, Auditory Impedance
OTOFLEX 100 TYE 1012
| Applicant | Gn Otometrics A/S, Taastrup, DK |
| Decision | Substantially Equivalent, Mar 31, 2004 |
| Received | Nov 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033645
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.