FDA 510(k) Application Details - K972284

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K972284
Device Name	Pump, Infusion
Applicant	BELMONT INSTRUMENT CORP. 780 BOSTON RD. BILLERICA, MA 01821 US Other 510(k) Applications for this Company
Contact	URAIWAN P LABADINI 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	06/19/1997
Decision Date	11/13/1997
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