FDA 510(k) Application Details - K993587

Device Classification Name	System, Hemodialysis, Access Recirculation Monitoring   More FDA Info for this Device
510(K) Number	K993587
Device Name	System, Hemodialysis, Access Recirculation Monitoring
Applicant	HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. ANDOVER, MA 01810-1085 US Other 510(k) Applications for this Company
Contact	MIKE HUDON 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	10/22/1999
Decision Date	01/20/2000
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