FDA 510(k) Application Details - K941460

Device Classification Name	System, Hemodialysis, Access Recirculation Monitoring   More FDA Info for this Device
510(K) Number	K941460
Device Name	System, Hemodialysis, Access Recirculation Monitoring
Applicant	FRESENIUS USA, INC. 2637 SHADELANDS DR. WALNUT CREEK, CA 94598 US Other 510(k) Applications for this Company
Contact	TOM FOLDEN 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	03/25/1994
Decision Date	07/03/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review