FDA 510(k) Application Details - K073581

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K073581
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	TEXAS INFRARED 1705 S. CAPITAL OF TEXAS HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	IAN P GORDON Other 510(k) Applications for this Contact
Regulation Number	884.2980   More FDA Info for this Regulation Number
Classification Product Code	LHQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2007
Decision Date	07/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review