FDA 510(k) Application Details - K062893

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

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510(K) Number K062893
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD.
ROME. 902, NO.15, LANE 28,
QINGJIANG ROAD
SHANGHAI 200233 CN
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Contact ZHAO J YU
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/27/2006
Decision Date 02/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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