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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 K200939
Device Name Electronic Blood Pressure Monitor
Applicant
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Yunyang Industrial Park
Danyang,  CN 212300
Applicant Contact Rui Li
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/08/2020
Decision Date 08/20/2020
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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