ICI P AND S SERIES IR CAMERAS


Device Classification Name

system, telethermographic (adjunctive use)

510(k) Number K073581
Device Name ICI P AND S SERIES IR CAMERAS
Applicant
TEXAS INFRARED
1705 s. capital of texas hwy
suite 500
austin, 
TX 
78746

Applicant Contact ian p gordon
Regulation Number 884.2980
Classification Product Code
LHQ  
Date Received 12/20/2007
Decision Date 07/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No