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FDA 510(k) Application Details - K140497
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K140497
Device Name
Computer, Diagnostic, Programmable
Applicant
CARDIOINSIGHT TECHNOLOGIES, INC
11000 CEDAR AVE SUITE 210
CLEVELAND, OH 44106 US
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Contact
CHRISTINA V VACCA
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
02/27/2014
Decision Date
11/19/2014
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
N
Expedited Review
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