FDA 510(k) Application Details - K954826

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K954826
Device Name	Pump, Infusion
Applicant	DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 MINNEAPOLIS, MN 55421-1014 US Other 510(k) Applications for this Company
Contact	ROBERT CERZA Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/1995
Decision Date	05/24/1996
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review