FDA 510(k) Application Details - K163683

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

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510(K) Number K163683
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant A&D COMPANY, LTD
1756 AUTOMATION PARKWAY
SAN JOSE, CA 95131 US
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Contact JERRY WANG
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/28/2016
Decision Date 05/03/2017
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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