FDA 510(k) Application Details - K093013

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

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510(K) Number K093013
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI 20030 CN
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Contact LEE FU
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/29/2009
Decision Date 01/08/2010
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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