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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 K171668
Device Name Bluetooth blood pressure monitor
Applicant
Visiomed Group SA
112 Av. Kleber
Paris,  FR
Applicant Contact Eric Sebban
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 Received06/05/2017
Decision Date 02/26/2018
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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