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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 K121355
Model BP-201M, BP-202N, BP-202H, BP-2206, BP-2208
Device Name WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Original Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
west lake economy & technology
zone
hangzhou, zhejiang,  CH 310030
Original Contact ren yunhua
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/04/2012
Decision Date 07/18/2012
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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