FDA 510(k) Application Details - K973609

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K973609
Device Name	Pump, Infusion
Applicant	BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 WINOOSKI, VT 05404-0998 US Other 510(k) Applications for this Company
Contact	MICHAEL N SEVIGNY 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	09/22/1997
Decision Date	12/18/1997
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