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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 K120634
Model TD-3124
Device Name U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu district
new taipei city,  TW 24888
Original Contact pinjung chen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/01/2012
Decision Date 07/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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