FDA 510(k) Application Details - K133870

Device Classification Name	Monitor, Electric For Gravity Flow Infusion Systems   More FDA Info for this Device
510(K) Number	K133870
Device Name	Monitor, Electric For Gravity Flow Infusion Systems
Applicant	COLEMAN LABORATORIES 1150 FIRST AVENUE, SUITE 501 KING OF PRUSSIA, PA 19406 US Other 510(k) Applications for this Company
Contact	LE-JUN YIN Other 510(k) Applications for this Contact
Regulation Number	880.2420   More FDA Info for this Regulation Number
Classification Product Code	FLN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2013
Decision Date	04/24/2014
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