510(k) K092111 ยท EWO Audiometer
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
| Applicant | Entomed AB, Malmo, SE |
| Decision | Substantially Equivalent, Oct 2, 2009 |
| Received | Jul 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092111
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.