FDA 510(k) Application Details - K020783

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K020783
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	TELESIS TECHNOLOGIES INC. 14F-3 & -4, NO.81, SEC 1, HSIN-TAI-WU RD. HIS-CHIH CITY, TAIPEI HSIEN 221 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	03/11/2002
Decision Date	06/07/2002
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