FDA 510(k) Application Details - K083753

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

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510(K) Number K083753
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
WU KU INDUSTRIAL PARK
TAIPEI HSIEN 248 TW
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Contact JASON CHENG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/17/2008
Decision Date 06/19/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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