FDA 510(k) Application Details - K183311

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K183311
Device Name	Pump, Infusion
Applicant	Ivenix, Inc. 50 High St., Suite 50 North Andover, MA 01845 US Other 510(k) Applications for this Company
Contact	John J. Sokolowski 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	11/29/2018
Decision Date	06/07/2019
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