K221338 is an FDA 510(k) clearance for the F&P Airvo 3. This device is classified as a High Flow/high Velocity Humidified Oxygen Delivery Device (Class II - Special Controls, product code QAV).
Submitted by Fisher & Paykel Healthcare (Manukau, NZ). The FDA issued a Cleared decision on January 27, 2023, 263 days after receiving the submission on May 9, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5454. Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification..
| 510(k) Number | K221338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2022 |
| Decision Date | January 27, 2023 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QAV - High Flow/high Velocity Humidified Oxygen Delivery Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5454 |
| Definition | Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification. |