510(k) K043219 ยท EWO Audiometer
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
| Applicant | Interacoustics AS, Minnesota MN, US |
| Decision | Substantially Equivalent, Feb 4, 2005 |
| Received | Nov 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043219
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.