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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 K121260
Device Name TROOPER OXYGEN CONCENTRATOR
Applicant
VBOX, INC.
2342 east county
road j
white bear lake,  MN  55110
Contact theodore jagger
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/26/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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