FDA 510(k) Application Details - K153162

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K153162
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	NOVOCOR MEDICAL SYSTEMS, INC 2 DAVIS DRIVE DURHAM, NC 27709 US Other 510(k) Applications for this Company
Contact	TAMMY CARREA Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	NCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	05/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review