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510(k) Data Aggregation

    K Number
    K033967
    Device Name
    TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
    Manufacturer
    FLIR SYSTEMS
    Date Cleared
    2004-03-09

    (78 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLIR SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flir devices are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes. Environment of use: hospital, sub-acute, public areas, i.e., airports
    Device Description
    Flir manufactures a number of IR camera's, they all include the same basis temperature measurement and sensing technology. They are non-contacting and employ passive infrared emissions for sensing temperature variations. The captured energy is processed by software to produce digital output values of the thermal energy captured by the camera's thermal sensors.
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