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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
Applicant
Maquet Critical Care AB
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
Maquet Critical Care AB
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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