AIRLIFE NEBULIZER CAP

Nebulizer (direct Patient Interface)

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Nebulizer Cap.

Pre-market Notification Details

Device IDK072119
510k NumberK072119
Device Name:AIRLIFE NEBULIZER CAP
ClassificationNebulizer (direct Patient Interface)
Applicant Cardinal Health 1430 WAUKEGAN RD. Mcgaw Park,  IL  60085
ContactSharon Nichols
CorrespondentNed Levine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-08-01
Decision Date2007-08-10
Summary:summary

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