FDA 510(k) Application Details - K071008

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K071008
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	RADIANT MEDICAL 250 CHESAPEAKE DR. REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	SCOTT A WILSON 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	04/09/2007
Decision Date	05/09/2007
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