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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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More FDA Info for this Product Code
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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