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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 K162616
Device Name Wrist Type Blood Pressure Monitor
Applicant
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
4f Bldg. C8,40 Jingshan Rd.
Econonic And Technolgical Development Zone
Xuzhou,  CN 102628
Applicant Contact YanLi Li
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, Dafangju, #25 Banbidian Rd.
Liyuan Town, Tongzhou District,  CN 101121
Correspondent Contact Ray Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/20/2016
Decision Date 03/09/2018
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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