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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 K073179
Device Name SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
Original Applicant
MAQUET CRITICAL CARE AB
1140 route 22 east
suite 202
bridgewater,  NJ  08807
Original Contact jamie yieh
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/13/2007
Decision Date 06/09/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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