510(k) K234058 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Aug 8, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234058
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.