510(k) K191818 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Mar 19, 2020 |
| Received | Jul 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191818
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.