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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 K120554
Model BP-102, PB-103, PB-1209, BP-1303A, BP-1304, PB-1305, BP-1307, BM-40, BP-103H, BP-201M, BP-202N, BP-202H, BP-2206, PB-220
Device Name ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
west lake economy & technology
zone
hangzhou, zhejiang, 
Contact ren yunhua
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/23/2012
Decision Date 08/10/2012
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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