510(k) K090804 ยท BZD Ventilator, Non-Continuous (Respirator)
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD
| Applicant | Innomed Technologies, Inc./Respcare, Inc., Coconut Creek FL, US |
| Decision | Substantially Equivalent, Nov 5, 2009 |
| Received | Mar 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090804
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.