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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K052396
FOIA Releasable 510(k) K052396
Device Name OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
Applicant
OXYSURE SYSTEMS, INC.
2611 INTERNET BLVD., SUITE 109
FRISCO,  TX  75034
Applicant Contact JULIAN T ROSS
Correspondent
OXYSURE SYSTEMS, INC.
2611 INTERNET BLVD., SUITE 109
FRISCO,  TX  75034
Correspondent Contact JULIAN T ROSS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/31/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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