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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 K181832
Device Name Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
Applicant
Guangdong Transtek Medical Electronics Co. Ltd
Zone A, No 105 Dongli Road, Torch Development District
Zhongshan,  CN 528437
Applicant Contact Nicole Hu
Correspondent
Guangdong Transtek Medical Electronics Co. Ltd
Zone A, No 105 Dongli Road, Torch Development District
Zhongshan,  CN 528437
Correspondent Contact Nicole Hu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/09/2018
Decision Date 04/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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