FDA 510(k) Application Details - K050239

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K050239
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	EM DIAGNOSTICS, INC. 1151 HOPE STREET STAMFORD, CT 06907 US Other 510(k) Applications for this Company
Contact	RICHARD KEEN 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	02/02/2005
Decision Date	03/16/2006
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