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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 K202891
Device Name Blood Pressure Monitor
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, #105, Dongli Rd., Torch Development District,
Zhongshan,  CN 528437
Applicant Contact Endless Chan
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 508, Block C, # 1029 Nanhai Ave., Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/28/2020
Decision Date 03/09/2021
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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