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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K101569
Device Name V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
Applicant
Taidoc Technology Corporation
3f, 5f, No 127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
3f, 5f, No 127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact TELING HSU
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/04/2010
Decision Date 03/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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