K233643 is an FDA 510(k) clearance for the F&P Airvo 3 NIV (PT311US). This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 9, 2024, 270 days after receiving the submission on November 13, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K233643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2023 |
| Decision Date | August 09, 2024 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |