FDA 510(k) Application Details - K994423

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

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510(K) Number K994423
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant VSM MEDTECH LTD.
555 13TH ST. NW
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/29/1999
Decision Date 03/28/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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