510(k) K100554 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, May 28, 2010 |
| Received | Feb 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100554
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.