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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
Device Name U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Correspondent Contact PINJUNG CHEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/01/2012
Decision Date 07/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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