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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
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE 17154
Applicant Contact Kribu Valdre
45 Barbour Pond Drive
Wayne,  NJ  07470
Correspondent Contact Mark N. Smith
Regulation Number868.5160
Classification Product Code
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
Recalls CDRH Recalls