FDA 510(k) Application Details - K150457

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K150457
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	ALFA THERMODIAGNOSTICS, INC. 9057 SOQUEL DRIVE, STE B-AA APTOS, CA 95033 US Other 510(k) Applications for this Company
Contact	Daniel Beilin 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	02/20/2015
Decision Date	04/10/2015
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