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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 K193386
Device Name Wrist Electronic Sphygmomanometer
Applicant
Shenzhen Changkun Technology Co., Ltd.
801, 3 Floor 4floor 5floor 6floor 7floor, B Bldg., #69,
Zhenbi Rd.
Shenzhen,  CN 518118
Applicant Contact Steve Li
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/06/2019
Decision Date 01/27/2021
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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