510(k) K122028 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
AURICAL HIT
| Applicant | Gn Otometrics, Naples FL, US |
| Decision | Substantially Equivalent, Oct 23, 2012 |
| Received | Jul 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122028
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.