THERMATREK IRIS-IV INFRARED IMAGING SYSTEM


Device Classification Name

system, telethermographic (adjunctive use)

510(k) Number K030165
Device Name THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
Original Applicant
THERMATREK
660 main st., south, #7
woodbury, 
CT 
06798

Original Contact david r balzer
Regulation Number 884.2980
Classification Product Code
LHQ  
Date Received 01/16/2003
Decision Date 04/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No