FDA 510(k) Application Details - K172653

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K172653
Device Name	Pump, Infusion
Applicant	ZOLL Medical Corporation 269 & 271 Mill Road Chelmsford, MA 01824-4105 US Other 510(k) Applications for this Company
Contact	Pooja Dalvi 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	09/05/2017
Decision Date	07/18/2018
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