FDA 510(k) Application Details - K051419

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K051419
Device Name	System, Thermal Regulating
Applicant	INDITHERM MEDICAL 5353 WAYZATA BLVD. SUITE 505 MINNEAPOLIS, MN 55416 US Other 510(k) Applications for this Company
Contact	M.W. (ANDY) ANDERSON 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	06/01/2005
Decision Date	04/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review