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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 K180098
Device Name SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE 17154
Applicant Contact Jerker Aberg
Correspondent
Maquet Medical System USA
45 Barbour Pond Drive
Wayne,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/16/2018
Decision Date 03/19/2019
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
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