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    K Number
    K102499
    Device Name
    DUOFERTILITY
    Manufacturer
    CAMBRIDGE TEMPERATURE CONCEPTS LTD.
    Date Cleared
    2011-12-20

    (476 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMBRIDGE TEMPERATURE CONCEPTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuoFertility Monitor is intended for measuring, and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
    Device Description
    The DuoFertility system is a computerized basal body temperature thermometer with the following features: - 1. A temperature Sensor with integrated data logger to monitor temperature throughout sleep and store the temperature readings - 2. Measuring accuracy within +/- 0.05 deg C - 3. Adhesive patches to hold the temperature Sensor against the users skin - 4. Radiofrequency communications hardware to transmit the stored temperature data to a receiving device - 5. Microprocessor based Reader to process and display temperature readings and fertility information.
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