PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT

Unit, Liquid-oxygen, Portable

ESSEX CRYOGENICS OF MISSOURI, INC.

The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Portable Therapeutic Liquid Oxygen Unit.

Pre-market Notification Details

Device IDK880183
510k NumberK880183
Device Name:PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT
ClassificationUnit, Liquid-oxygen, Portable
Applicant ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis,  MO  63123
ContactFred Snyder
CorrespondentFred Snyder
ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis,  MO  63123
Product CodeBYJ  
CFR Regulation Number868.5655 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-15
Decision Date1988-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815363020025 K880183 000

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