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FDA 510(k)

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

K-Number: K191624 · 2020-03-09

ApplicantFisher & Paykel Healthcare Limited
Decision Date2020-03-09
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is a medical device manufactured by Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2020-03-09 under approval number K191624. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is a medical device that received FDA 510(k) clearance on 2020-03-09. It is manufactured by Fisher & Paykel Healthcare Limited. The 510(k) number is K191624.

When was F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version approved by the FDA?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version received FDA 510(k) clearance on 2020-03-09, under approval number K191624.

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

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is manufactured by Fisher & Paykel Healthcare Limited.

What is the FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is MNT.

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Related Devices (Code: MNT)

K170367Nivairo 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 SmallFisher and Paykel Healthcare Limited K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB K240779Vivo 3Breas Medical AB K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. K242931HFT750UMekics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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