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510(k) Data Aggregation

    K Number
    K983295
    Device Name
    BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
    Manufacturer
    BRAUN AG
    Date Cleared
    1999-03-15

    (175 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
    Device Description
    The Braun Thermoscan IRT 3020/3520 Thermometer is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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