FDA 510(k) Application Details - K014299

Device Classification Name Plethysmograph, Impedance

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510(K) Number K014299
Device Name Plethysmograph, Impedance
Applicant SORBA MEDICAL SYSTEMS, INC.
165 BISHOPS WAY, SUITE 152
BROOKFIELD, WI 53005 US
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Contact JILL BARNEY
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 12/31/2001
Decision Date 01/30/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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