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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 K122482
Device Name TRANSTEK WRIST BLOOD PRESSURE MONITOR
Original Applicant
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
no. 1 fanghua street
hi-tech zone
chengdu,  CN 610041
Original Contact leo wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/14/2012
Decision Date 10/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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