510(k) K090915 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
STERILE WATER FOR INHALATION FLEX BAG, USP
| Applicant | Cardinal Health, Inc., Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Nov 18, 2009 |
| Received | Apr 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090915
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.