FDA 510(k) Application Details - K003332

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K003332
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	MEDITHERM, INC. 7407 DOVER LN. PARKLAND, FL 33067 US Other 510(k) Applications for this Company
Contact	PETER LEANDO 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	10/24/2000
Decision Date	02/21/2001
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