FDA 510(k) Application Details - K012310

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

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510(K) Number K012310
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HEALTH & LIFE CO., LTD.
6F,NO.407, CHUNG SHAN RD.
SEC.02, CHUNG HO CITY
TAIPEI HSIEN 235 TW
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Contact SUSAN CHEN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 07/23/2001
Decision Date 08/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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