FDA 510(k) Application Details - K023925

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K023925
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	IX-DR, INC. 120 STATE HOWELL, MI 48843 US Other 510(k) Applications for this Company
Contact	WILLIAM J O'NEILL 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	11/25/2002
Decision Date	02/11/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review