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

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Fisher & Paykel Healthcare Limited

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for F&p Nivairo Rt047 Vented Hospital Full Face Mask, Anti-asphyxiation Valve Version.

Pre-market Notification Details

Device IDK191624
510k NumberK191624
Device Name:F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
ClassificationVentilator, Continuous, Minimal Ventilatory Support, Facility Use
Applicant Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place Auckland,  NZ 2013
ContactNicholas Yap
CorrespondentReena Daken
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place Auckland,  NZ 2013
Product CodeMNT  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-18
Decision Date2020-03-09

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