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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
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