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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K120778
Device Name BRIVO MR355
Original Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
no.2, yong chang north rd.
beijing econ.&tech.dev.area
beijing,  CH 100176
Original Contact ruoqian liu
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/14/2012
Decision Date 03/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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