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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K120673
Device Name DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
Original Applicant
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
building 7, zhu keng industrial
zone, ping shan, long gang district
shenzhen,  CN 518118
Original Contact patrick chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/05/2012
Decision Date 02/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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