F&P 850 AirSpiral Adult NIV And NHF Circuit Kit

Humidifier, Respiratory Gas, (direct Patient Interface)

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 850 Airspiral Adult Niv And Nhf Circuit Kit.

Pre-market Notification Details

Device IDK212031
510k NumberK212031
Device Name:F&P 850 AirSpiral Adult NIV And NHF Circuit Kit
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
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 CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-29
Decision Date2022-04-22

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