510(k) K211096 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Optiflow Oxygen Kit
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Apr 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211096
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.