FDA 510(k) Application Details - K200176

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K200176
Device Name	Pump, Infusion
Applicant	Repro-Med Systems, Inc., dba KORU Medical Systems 24 Carpenter Road Chester, NY 10918 US Other 510(k) Applications for this Company
Contact	Cynthia Lacatena 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	01/24/2020
Decision Date	12/15/2021
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