FDA 510(k) Application Details - K243855

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K243855
Device Name	Pump, Infusion
Applicant	CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Darin Oppenheimer 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	12/16/2024
Decision Date	04/25/2025
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