FDA 510(k) Application Details - K211124

Device Classification Name	More FDA Info for this Device
510(K) Number	K211124
Device Name	Dose IQ Safety Software
Applicant	Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 US Other 510(k) Applications for this Company
Contact	Michelle Rixie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2021
Decision Date	08/30/2022
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