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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 Dr.
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
Predetermined Change
Control Plan Authorized		 No
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