FDA 510(k) Application Details - K092514

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

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510(K) Number K092514
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
BLDG 2, BAIMIAO IND. PARK
ECONOMIC DEVELOPMENT ZONE
WUCHANG, HANGZHOU, ZHEJIANG 310023 CN
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Contact JI BO
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 08/17/2009
Decision Date 12/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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