ICI P AND S SERIES IR CAMERAS

System, Telethermographic (adjunctive Use)

TEXAS INFRARED

The following data is part of a premarket notification filed by Texas Infrared with the FDA for Ici P And S Series Ir Cameras.

Pre-market Notification Details

Device IDK073581
510k NumberK073581
Device Name:ICI P AND S SERIES IR CAMERAS
ClassificationSystem, Telethermographic (adjunctive Use)
Applicant TEXAS INFRARED 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin,  TX  78746
ContactIan P Gordon
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeLHQ  
CFR Regulation Number884.2980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-12-20
Decision Date2008-07-11
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.