FDA 510(k) Application Details - K223606

Device Classification Name	More FDA Info for this Device
510(K) Number	K223606
Device Name	LifeShieldÖ Infusion Safety Software Suite
Applicant	ICU Medical, Inc. 600 N. Field Drive Lake Forest, IL 60045 US Other 510(k) Applications for this Company
Contact	Pernell Abrantes 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	12/02/2022
Decision Date	08/24/2023
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