FDA 510(k) Application Details - K092806

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

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510(K) Number K092806
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 09/11/2009
Decision Date 10/09/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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