FDA 510(k) Application Details - K073630

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K073630
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
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	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2007
Decision Date	01/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review