510(k) K212031 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Apr 22, 2022 |
| Received | Jun 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212031
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.