FDA 510(k) Application Details - K082599

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

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510(K) Number K082599
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant CNSYSTEM MEDIZINTECHNIK AG
REININGHAUSSTRASSE 13
GRAZ 8020 AT
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Contact SUMPER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/08/2008
Decision Date 10/17/2008
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 Y
Expedited Review



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