FDA 510(k) Application Details - K153226

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K153226
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	ZOLL CIRCULATION, INC. 2000 RINGWOOD AVE. SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	SAM NANAVATI 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	11/06/2015
Decision Date	03/24/2016
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review