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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 K160665
Device Name FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
Applicant
MAQUET CRITICAL CARE AB
RONTGENVAGEN 2
SOLNA,  SE SE-171 54
Applicant Contact CARINA LUNDBERG
Correspondent
MAQUET MEDICAL SYSTEMS USA
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/09/2016
Decision Date 03/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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