RESPIR THER HUMID CONTAIN STERILE WATER FOR USP

Humidifier, Respiratory Gas, (direct Patient Interface)

AUTOMATIC LIQUID PACKAGING, INC.

The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Respir Ther Humid Contain Sterile Water For Usp.

Pre-market Notification Details

Device IDK853146
510k NumberK853146
Device Name:RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock,  IL  60098
ContactFrank Leo
CorrespondentFrank Leo
AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock,  IL  60098
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-29
Decision Date1985-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10190752141643 K853146 000

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