510(k) K143646 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Mar 5, 2015 |
| Received | Dec 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143646
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.