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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K033000
Device Name NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
Applicant
Essex Cryogenics of Missouri, Inc.
8007 Chivvis Dr.
St. Louis,  MO  63123
Applicant Contact ELIZABETH HUNNICUTT
Correspondent
Essex Cryogenics of Missouri, Inc.
8007 Chivvis Dr.
St. Louis,  MO  63123
Correspondent Contact ELIZABETH HUNNICUTT
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/25/2003
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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