FDA 510(k) Application Details - K231918

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K231918
Device Name	Pump, Infusion
Applicant	Koru Medical Systems 100 Corporate Dr Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	Emily DiMambro 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	06/29/2023
Decision Date	11/03/2023
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