FDA 510(k) Application Details - K983321

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K983321
Device Name	Pump, Infusion
Applicant	BAXA CORP. 9712 S. ALTAMONT DR. SANDY, UT 84092 US Other 510(k) Applications for this Company
Contact	WILLIAM E MCKAY 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	09/22/1998
Decision Date	10/06/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review