FDA 510(k) Application Details - K101641

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K101641
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	AG DIGITAL TECHNOLOGY CORP. 2904 N. BOLDT DRIVE FLAGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	JENNIFER REICH 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	06/10/2010
Decision Date	06/16/2011
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	N
Expedited Review