Cleared Traditional

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

K191624 · Fisher & Paykel Healthcare Limited · Anesthesiology

Mar 2020

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K191624 is an FDA 510(k) clearance for the F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on March 9, 2020, 265 days after receiving the submission on June 18, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K191624 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2019
Decision Date	March 09, 2020
Days to Decision	265 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