FDA 510(k) Application Details - K141984

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

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510(K) Number K141984
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Ro
NANKAI DISTRICT
TIANJIN 300190 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 07/21/2014
Decision Date 04/29/2015
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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