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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 K112274
Device Name U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
Applicant
Taidoc Technology Corporation
3f, 5f, No 127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact LINDA KO
Correspondent
Taidoc Technology Corporation
3f, 5f, No 127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact LINDA KO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/08/2011
Decision Date 12/21/2011
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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