FDA 510(k) Application Details - K033623

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K033623
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	INNERCOOL THERAPIES, INC. 3931 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	STEVE REITZLER 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	11/18/2003
Decision Date	05/21/2004
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