The following data is part of a premarket notification filed by Texas Infrared with the FDA for Ici P And S Series Ir Cameras.
Device ID | K073581 |
510k Number | K073581 |
Device Name: | ICI P AND S SERIES IR CAMERAS |
Classification | System, Telethermographic (adjunctive Use) |
Applicant | TEXAS INFRARED 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
Contact | Ian P Gordon |
Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | LHQ |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-12-20 |
Decision Date | 2008-07-11 |
Summary: | summary |