510(k) K083861 ยท ETY Tester, Auditory Impedance
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
| Applicant | Interacoustics AS, Assens, DK |
| Decision | Substantially Equivalent, Apr 9, 2009 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083861
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.