FDA 510(k) Application Details - K130867

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K130867
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	VITAL SIGNS, INC., A GE HEALTHCARE COMPANY 20 CAMPUS RD TOTOWA, NJ 07512 US Other 510(k) Applications for this Company
Contact	STACIE GEFFNER-ATIYA 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	03/28/2013
Decision Date	06/14/2013
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