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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 K182018
Device Name Bluetooth blood pressure monitor
Applicant
Shenzhen Kingyield Technology Co., Ltd.
Section C2, Fuhai Industrial Zone, Fuyong Town,
Baoan District
Shenzhen,  CN 518000
Applicant Contact Dacheng Gong
Correspondent
Shenzhen Kingyield Technology Co., Ltd.
Section C2, Fuhai Industrial Zone, Fuyong Town,
Baoan District
Shenzhen,  CN 518000
Correspondent Contact Dacheng Gong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/27/2018
Decision Date 10/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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