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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K101259
Model TD-8002
Device Name V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 24888
Original Contact debra liang
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/04/2010
Decision Date 06/17/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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