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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 K120785
Device Name OMNI 3 OXYGEN SYSTEM
Applicant
CAIRE, INC.
12230 WORLD TRADE
DRIVE, SUITE 100
SAN DIEGO,  CA  92128
Applicant Contact BRIAN JARRELL
Correspondent
CAIRE, INC.
12230 WORLD TRADE
DRIVE, SUITE 100
SAN DIEGO,  CA  92128
Correspondent Contact BRIAN JARRELL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/15/2012
Decision Date 10/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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