FDA 510(k) Application Details - K100658

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K100658
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant TaiDoc Technology Corporation
3F, 5F, NO 127 WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 248 TW
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Contact NICKY PAN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/08/2010
Decision Date 07/09/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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