510(k) K062263 ยท CAF Nebulizer (Direct Patient Interface)
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Aug 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062263
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.