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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 K123669
Device Name TRANSTEK WRIST BLOOD PRESSURE MONITOR
Applicant
Zhongshan Transtek Electronics Co., Ltd.
#1 Fanghua St., Hi-Tech District
Chengdu, Sichuan,  CN 610041
Applicant Contact LEO WANG
Correspondent
Zhongshan Transtek Electronics Co., Ltd.
#1 Fanghua St., Hi-Tech District
Chengdu, Sichuan,  CN 610041
Correspondent Contact LEO WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/29/2012
Decision Date 12/21/2012
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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