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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 K121167
Device Name CAIRE COMPANION 5 OXYGEN CONCENTRATOR
Original Applicant
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground,  GA  30107
Original Contact ben kadrlik
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/17/2012
Decision Date 05/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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