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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 K161530
Device Name Bluetooth blood pressure monitor
Applicant
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
BLDG C, FUHAI INDUSTRIAL ZONE, FUHAI RD, FUYONG TOWN, BAOAN,
SHENZHEN,  CN 518000
Applicant Contact Dacheng Gong
Correspondent
SHENZHEN JOYANTECH CONSULTING CO., LTD.
2032#, INTERNATIONAL MAYOR COMMUNICATION CENTER, SHIZHOU
SHIZHOU ZHONG ROAD 55#, NA
SHENZHEN,  CN 518100
Correspondent Contact Field. Fu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/02/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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