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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
twinsburg,  OH  44087
Correspondent Contact daniel w lehtonen
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received12/20/2007
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
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