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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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