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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 K191027
Device Name Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE 171 54
Applicant Contact Kribu Valdre
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Mark N. Smith
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/18/2019
Decision Date 03/18/2020
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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