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510(k) K122400

CARDIOX FLOW DETECTION SYSTEM by Cardiox Corp. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2013
Date Received
August 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

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