FDA 510(k) Application Details - K123882

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

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510(K) Number K123882
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant AGELESS HEALTH INDUSTRIAL
3F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA
NO. 33 SHENBEI ROAD, CHANGPING
DONGGUAN, GUANGDONG 523570 CN
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Contact VICTOR WAN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/17/2012
Decision Date 08/14/2013
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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