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FDA 510(k) Application Details - K083395

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

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510(K) Number K083395
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ANDON HEALTH CO.,LTD
NO 31, CHANGJIANG ROAD
NANKAI DISTRICT
TIANJIN 300193 CH
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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 11/19/2008
Decision Date 02/27/2009
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review N



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