510(k) K131957 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Dec 4, 2013 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131957
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.