FDA 510(k) Application Details - K122400

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K122400
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	CARDIOX CORP. 4100 HORIZONS DRIVE, SUITE 100 COLUMBUS, OH 43220 US Other 510(k) Applications for this Company
Contact	KAREN MATIS Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2012
Decision Date	11/05/2013
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