FDA 510(k) Application Details - K131121

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

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510(K) Number K131121
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
CHUNG HO CITY, TAIPEI 235 TW
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Contact SARAH SU
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 04/22/2013
Decision Date 05/29/2013
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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