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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 K162089
Device Name Blood Pressure Monitor
Applicant
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Applicant Contact LEI CHEN
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Correspondent Contact LEI CHEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/28/2016
Decision Date 02/10/2017
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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