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510(k) K033967

TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P by Flir Systems — Product Code LHQ

K033967 is an FDA 510(k) premarket notification submitted by Flir Systems for the device "TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P". The FDA issued a decision of Substantially Equivalent on March 9, 2004. 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
March 9, 2004
Date Received
December 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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