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    K Number
    K180767
    Device Name
    FEMON Banana Thermometer
    Date Cleared
    2019-01-22

    (305 days)

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

    Life Science Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FEMON Banana Thermometer is a battery operated electronic device with intended use of measuring human body temperature. This device is intended for armpit temperature measurement from ages 29 days and older.
    Device Description
    The FEMON Banana Thermometer is a thermometer composed of a body patch to be directly attached to the patient's skin on armpit. The temperature information is then to be retrieved from the patch to the mobile phone application via Bluetooth.
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