FDA 510(k) Application Details - K101259

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K101259
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact DEBRA LIANG
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 05/04/2010
Decision Date 06/17/2010
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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