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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K201874
Device Name Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE 17154
Applicant Contact David Ardanius
Correspondent
Getinge
45 Barbour Pond Drive
Wayne,  NJ  07470
Correspondent Contact Mark N Smith
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/07/2020
Decision Date 04/20/2021
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
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