F&P Visairo NIV Mask Range

Ventilator, Continuous, Facility Use

Fisher & Paykel Healthcare Ltd

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p Visairo Niv Mask Range.

Pre-market Notification Details

Device IDK203449
510k NumberK203449
Device Name:F&P Visairo NIV Mask Range
ClassificationVentilator, Continuous, Facility Use
Applicant Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland,  NZ 2013
ContactReena Daken
CorrespondentReena Daken
Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland,  NZ 2013
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-04-14

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