FDA 510(k) Application Details - K110597

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K110597
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	EDWARDS LIFESCIENCES ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	MARGUERITE THOMLINSON 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	03/02/2011
Decision Date	06/14/2011
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