FDA 510(k) Application Details - K980165

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K980165
Device Name	Accessories, Pump, Infusion
Applicant	DATREND SYSTEMS, INC. UNIT 106-3070 NORLAND AVE. BURNABY, BRITISH COLUMBIA V5B 3A6 CA Other 510(k) Applications for this Company
Contact	RON EVANS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1998
Decision Date	04/20/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review