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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 K200716
Device Name Electronic Blood Pressure Monitor
Applicant
Shenzhen Pango Electronic Co., Ltd.
#25, 1st Industrial Park, Fenghuang Rd.
Xikeng, Henggang, Longgang District
Shenzhen,  CN 518115
Applicant Contact Xioyun Yang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/18/2020
Decision Date 12/04/2020
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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