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510(k) Data Aggregation

    K Number
    K032714
    Device Name
    CARDICARE MODEL MT-301F & MT-301C
    Manufacturer
    LUMISCOPE CO., INC.
    Date Cleared
    2003-10-22

    (50 days)

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

    LUMISCOPE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardicare Model MT-301C and Model MT-301F digital thermometers are intended for use in the measurement of oral, axillary and rectal body temperature.
    Device Description
    The Cardicare Model MT-301F & MT-301C Thermometers are thermometers of standard electrical transducer design, consisting of a sensor tip, connecting probe and display unit. The probe consists of a transducer and supporting plastic case, which houses the connection between the sensor and the circuitry. The display unit houses a 1.55V DC button battery, LCD and push button switch for controlling temperature and alert beeper.
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    K Number
    K954792
    Device Name
    LUMISCOPE MODEL 2018 THERMOMETER
    Manufacturer
    LUMISCOPE CO., INC.
    Date Cleared
    1996-06-21

    (247 days)

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

    LUMISCOPE CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.
    Device Description
    The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper.
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