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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 K161886
Device Name Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, #105, Dongli Rd., Torch Development District,
Zhongshan,  CN 528437
Applicant Contact ADA ZHANG
Correspondent
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, #105, Dongli Rd., Torch Development District,
Zhongshan,  CN 528437
Correspondent Contact ADA ZHANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/11/2016
Decision Date 10/14/2016
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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