FDA 510(k) Application Details - K053645

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K053645
Device Name	System, Thermal Regulating
Applicant	ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DAVID WESTLIN Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2005
Decision Date	03/09/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review