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FDA 510(k) Application Details - K101569
Device Classification Name
Electrocardiograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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