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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K122253
Model B20
Device Name PROCARE MONITOR B20
Original Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
8200 west tower ave
milwaukee,  WI  53223
Original Contact robert casarsa
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/27/2012
Decision Date 03/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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