FDA 510(k) Application Details - K152208

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K152208
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	BELMONT INSTRUMENT CORPORATION 780 BOSTON ROAD BILLERICA, MA 01821 US Other 510(k) Applications for this Company
Contact	URAIWAN P LABADINI 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	08/07/2015
Decision Date	09/02/2015
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