FDA 510(k) Application Details - K161613

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K161613
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	RanD S.r.l. via Statale 12, 62 Medolla 41036 IT Other 510(k) Applications for this Company
Contact	Simone Ceretti 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	06/10/2016
Decision Date	12/28/2016
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