AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

Nebulizer (direct Patient Interface)

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Misty Finity Large Volume Continuous Nebulizer.

Pre-market Notification Details

Device IDK041418
510k NumberK041418
Device Name:AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant Cardinal Health 1500 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactLavenia Ford
CorrespondentNed Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-05-27
Decision Date2004-06-10
Summary:summary

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