510(k) K113831 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
PRIMUS HEARING INSTRUMENT TEST UNIT
| Applicant | Auditdata A/S, Taastrup, DK |
| Decision | Substantially Equivalent, Apr 19, 2012 |
| Received | Dec 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113831
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.