FDA 510(k) Application Details - K030739

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K030739
Device Name	Pump, Infusion
Applicant	INFUSION DYNAMICS, INC. 5340 SPECTRUM DRIVE, SUITE N FREDERICK, MD 21703 US Other 510(k) Applications for this Company
Contact	THOMAS BECZE 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	03/10/2003
Decision Date	01/14/2004
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