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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
Device Name WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Original Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
west lake economy & technology
zone
hangzhou, zhejiang,  CN 310030
Original Contact ren yunhua
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/04/2012
Decision Date 07/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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