FDA 510(k) Application Details - K083749

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K083749
Device Name	System, Ecg Analysis
Applicant	QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	MARY KAY JENSEN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2008
Decision Date	03/10/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review