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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 K151814
Device Name SERVO-U Ventilator System, SERVO-n Ventilator System
Applicant
MAQUET CRITICAL CARE AB
RONTGENVAGEN 2
SOLNA,  SE SE-171 54
Applicant Contact MARIA VON BAHR
Correspondent
MAQUET MEDICAL SYSTEMS USA
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact LIA GONZALEZ
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/06/2015
Decision Date 12/21/2015
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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