DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM


Device Classification Name

system, telethermographic (adjunctive use)

510(k) Number K023434
Device Name DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
Original Applicant
DOREX, INC.
954 north lemon st.
orange, 
CA 
92867

Original Contact mel kutas
Regulation Number 884.2980
Classification Product Code
LHQ  
Date Received 10/15/2002
Decision Date 11/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No