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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact