FDA 510(k) Application Details - K220417

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K220417
Device Name	Pump, Infusion
Applicant	Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Jennifer Hoogheem 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	02/14/2022
Decision Date	04/29/2022
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