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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 K123149
Device Name SERVO-I VENTILATOR SYSTEM
Applicant
MAQUET CRITICAL CARE AB
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
MAQUET CRITICAL CARE AB
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact WHITNEY TORNING
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/05/2012
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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