FDA 510(k) Application Details - K073712

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K073712
Device Name	System, Thermal Regulating
Applicant	ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. LOUDON, TN 37774 US Other 510(k) Applications for this Company
Contact	JON R HERMANSON 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	12/31/2007
Decision Date	06/06/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review