K222292 is an FDA 510(k) clearance for the F&P myAirvo 3. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Fisher & Paykel Healthcare (Manukau, NZ). The FDA issued a Cleared decision on May 8, 2024, 649 days after receiving the submission on July 29, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K222292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2022 |
| Decision Date | May 08, 2024 |
| Days to Decision | 649 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 |