FDA 510(k) Application Details - K101569

Device Classification Name Electrocardiograph

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510(K) Number K101569
Device Name Electrocardiograph
Applicant TaiDoc Technology Corporation
3F, 5F, NO 127 WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact TELING HSU
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 06/04/2010
Decision Date 03/01/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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