510(k) K070312 ยท ETY Tester, Auditory Impedance
EARCHECK ACOUSTIC REFLECTOMETER
| Applicant | Innovia Medical, LLC, Littleton CO, US |
| Decision | Substantially Equivalent, Mar 2, 2007 |
| Received | Feb 1, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070312
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.