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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 K133958
Device Name FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
Applicant
MAQUET CRITICAL CARE AB
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact LIA LIEBGOLD
Correspondent
MAQUET CRITICAL CARE AB
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact LIA LIEBGOLD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received12/24/2013
Decision Date 03/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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