510(k) K110860 ยท CAF Nebulizer (Direct Patient Interface)
COMP A-I-R
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Sep 2, 2011 |
| Received | Mar 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110860
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.