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510(k) Data Aggregation

    K Number
    K033077
    Device Name
    EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
    Manufacturer
    Date Cleared
    2004-04-30

    (214 days)

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

    METATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.
    Device Description
    The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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    K Number
    K033082
    Device Name
    9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
    Manufacturer
    Date Cleared
    2003-12-03

    (65 days)

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

    METATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an electronic clinical thermometer using a themistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
    Device Description
    The 9 second Digital Thermometer is designed to measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed.
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    K Number
    K020520
    Device Name
    EASYTEM EAR THERMOMETER, MODEL BT-020
    Manufacturer
    Date Cleared
    2002-08-06

    (168 days)

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

    METATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an electronic clinical thermometer using an infrared sensor to detect body temperature via the auditory canal in the neonatal, pediatric and adult population used at home.
    Device Description
    The easytem Ear Thermometer is a hand held instrument that measures body 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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