F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

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 Optiflow 3s Nasal Cannula (small, Medium, Large).

Pre-market Notification Details

Device IDK191818
510k NumberK191818
Device Name:F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
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)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-05
Decision Date2020-03-19

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