FDA 510(k) Application Details - K963136

Device Classification Name	Controller, Infusion, Intravascular, Electronic   More FDA Info for this Device
510(K) Number	K963136
Device Name	Controller, Infusion, Intravascular, Electronic
Applicant	HEALTH WATCH, INC. 20310 SW 48TH ST. FT. LAUDERDALE, FL 33332 US Other 510(k) Applications for this Company
Contact	JOHN D GREENBAUM Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/1996
Decision Date	10/10/1997
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