K234058 is an FDA 510(k) clearance for the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 8, 2024, 230 days after receiving the submission on December 22, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K234058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | August 08, 2024 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |