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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gas-machine, anesthesia
510(k) Number K112114
Device Name MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
Original Applicant
MAQUET CRITICAL CARE AB
45 barbour pond drive
wayne,  NJ  07470
Original Contact whitney torning
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/25/2011
Decision Date 01/13/2012
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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