FDA 510(k) Application Details - K123130

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

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510(K) Number K123130
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant TAIWAN SCIENTIFIC CORPORATION
10F, 88-4, MING-CHIUAN RD,
SHIN-DIAN DISTRIC
NEW TAIPEI 23141 TW
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Contact DEHCHUAN SUN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/04/2012
Decision Date 09/17/2013
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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