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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 K091897
Device Name BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 24888
Applicant Contact ERICA LI
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 24888
Correspondent Contact ERICA LI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/24/2009
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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