FDA 510(k) Application Details - K163708

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K163708
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	Quality In Flow Ltd. Kibutz Einat POB 29 Kibutz Einat 4880500 IL Other 510(k) Applications for this Company
Contact	Neta Sherman Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2016
Decision Date	04/20/2017
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