FDA 510(k) Application Details - K113259

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K113259
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	UE LIFESCIENCES, INC. 4435 LOBELLA COURT CHESTER SPRINGS, PA 19425 US Other 510(k) Applications for this Company
Contact	MIHIR SHAH 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	11/04/2011
Decision Date	02/10/2012
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