510(k) K033710 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
| Applicant | Fisher & Paykel Healthcare, Ltd., Panmure, Auckland, NZ |
| Decision | Substantially Equivalent, Apr 13, 2004 |
| Received | Nov 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033710
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.