AirLife Adult Heated Wire BiPAP/NIV Circuit

Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

Vyaire Medical

The following data is part of a premarket notification filed by Vyaire Medical with the FDA for Airlife Adult Heated Wire Bipap/niv Circuit.

Pre-market Notification Details

Device IDK170378
510k NumberK170378
Device Name:AirLife Adult Heated Wire BiPAP/NIV Circuit
ClassificationHeater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Applicant Vyaire Medical 75 North Fairway Drive Vernon Hills,  IL  60061
ContactSharon Nichols
CorrespondentColleen Watson (o'keeffe)
Vyaire Medical 75 North Fairway Drive Vernon Hills,  IL  60061
Product CodeBZE  
CFR Regulation Number868.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-07
Decision Date2017-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889483617007 K170378 000
30889483595842 K170378 000

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