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    K Number
    K021048
    Device Name
    THERMOMETER MODELS ST8631
    Manufacturer
    Z7 INTERNATIONAL
    Date Cleared
    2002-04-22

    (21 days)

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

    Z7 INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
    Device Description
    The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
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