FDA 510(k) Application Details - K131154

Device Classification Name	Pump, Infusion, Enteral   More FDA Info for this Device
510(K) Number	K131154
Device Name	Pump, Infusion, Enteral
Applicant	ZEVEX, INC. 4314 ZEVEX PARK LN. SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	NILOUFAR SAMIMI Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2013
Decision Date	02/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review