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FDA 510(k) Application Details - K122247
Device Classification Name
Computer, Diagnostic, Pre-Programmed, Single-Function
More FDA Info for this Device
510(K) Number
K122247
Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant
LIDCO LTD.
16 ORSMAN RD.
LONDON N15QJ GB
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Contact
GREGORY SPELLER
Other 510(k) Applications for this Contact
Regulation Number
870.1435
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Classification Product Code
DXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/27/2012
Decision Date
03/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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