Cleared Traditional

F&P Airvo 3 NIV (PT311US)

K233643 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology
Aug 2024
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K233643 is an FDA 510(k) clearance for the F&P Airvo 3 NIV (PT311US), 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 review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K233643 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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