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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
Device Name V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 24888
Applicant Contact debra liang
Correspondent
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 24888
Correspodent Contact debra liang
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/04/2010
Decision Date 06/17/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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