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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 K192604
Device Name Servo-air 4.0 Ventilator System
Applicant
Maquet Critica Care AB
Röntgenvägen 2
Solna,  SE 17154
Applicant Contact David Ardanius
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Mark N. Smith
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/20/2019
Decision Date 06/18/2020
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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