FDA 510(k) Application Details - K050783

Device Classification Name	Monitor, Electric For Gravity Flow Infusion Systems   More FDA Info for this Device
510(K) Number	K050783
Device Name	Monitor, Electric For Gravity Flow Infusion Systems
Applicant	INTEGRATED SENSING SYSTEMS, INC. 391 AIRPORT INDUSTRIAL DRIVE YPSILANTI, MI 48198 US Other 510(k) Applications for this Company
Contact	STEPHEN GOLDNER, JD, RAC Other 510(k) Applications for this Contact
Regulation Number	880.2420   More FDA Info for this Regulation Number
Classification Product Code	FLN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2005
Decision Date	02/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review