FDA 510(k) Application Details - K042566

Device Classification Name	System, Hemodialysis, Access Recirculation Monitoring   More FDA Info for this Device
510(K) Number	K042566
Device Name	System, Hemodialysis, Access Recirculation Monitoring
Applicant	VASC-ALERT, INC. 1807 WEST SUNNYSIDE AVE. SUITE 301 CHICAGO, IL 60640 US Other 510(k) Applications for this Company
Contact	JOHN B KENNEDY Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	MQS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2004
Decision Date	11/08/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review