Cleared Traditional

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small

K170367 · Fisher and Paykel Healthcare Limited · Anesthesiology

Aug 2017

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K170367 is an FDA 510(k) clearance for the Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on August 24, 2017, 199 days after receiving the submission on February 6, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K170367 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2017
Decision Date	August 24, 2017
Days to Decision	199 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