FDA 510(k) Application Details - K221319

Device Classification Name	More FDA Info for this Device
510(K) Number	K221319
Device Name	BD AlarisÖ Pump Epidural Infusion Set
Applicant	CareFusion 10020 Pacific Mesa Blvd San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Paulina Davis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2022
Decision Date	07/21/2023
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