FDA 510(k) Application Details - K014063

Device Classification Name Plethysmograph, Impedance

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510(K) Number K014063
Device Name Plethysmograph, Impedance
Applicant CNSYSTEMS MEDIZINTECHNIK GMBH
BAUMKIRCHERSTRASSE 1
A-8020 GRAZ
EUROPE AT
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Contact CHRISTIAN WAGNER
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 12/11/2001
Decision Date 02/07/2002
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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