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510(k) K073581

ICI P AND S SERIES IR CAMERAS by Texas Infrared — Product Code LHQ

K073581 is an FDA 510(k) premarket notification submitted by Texas Infrared for the device "ICI P AND S SERIES IR CAMERAS". The FDA issued a decision of Substantially Equivalent on July 11, 2008. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2008
Date Received
December 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

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FDA data resources