FDA 510(k) Application Details - K131247

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K131247
Device Name	Pump, Infusion, Elastomeric
Applicant	MFS - MEDICAL FLOW SYSTEMS LTD ELT BUILDING, DORA INDUSTRIAL ZONE, SHLOMI 22832, ISRAL SHLOMI 22832 IL Other 510(k) Applications for this Company
Contact	OFER SHAY Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2013
Decision Date	08/14/2013
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