AirLife Infant Single Limb Heated Wire Circuit

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

CAREFUSION INC

The following data is part of a premarket notification filed by Carefusion Inc with the FDA for Airlife Infant Single Limb Heated Wire Circuit.

Pre-market Notification Details

Device IDK151959
510k NumberK151959
Device Name:AirLife Infant Single Limb Heated Wire Circuit
ClassificationHeater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Applicant CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills,  IL  60061
ContactErika Fernandez
CorrespondentErika Fernandez
CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills,  IL  60061
Product CodeBZE  
CFR Regulation Number868.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2016-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50885403288911 K151959 000
50885403276192 K151959 000

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