FDA 510(k) Application Details - K070826

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

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510(K) Number K070826
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
NO.31, CHANGJIANG ROAD,
NANKAI DISTRICT
TIANJIN 300193 CN
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Contact LIU YI
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 03/26/2007
Decision Date 08/15/2007
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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