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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
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,  CN 310030
Applicant Contact REN YUNHUA
Correspondent
Sejoy Electronics & Instruments Co., Ltd.
West Lake Economy & Technology
Zone
Hangzhou, Zhejiang,  CN 310030
Correspondent Contact REN YUNHUA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/23/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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