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510(k) Data Aggregation

    K Number
    K020808
    Device Name
    FERTILITE OV
    Manufacturer
    PHEROMONE SCIENCES CORP.
    Date Cleared
    2002-09-23

    (195 days)

    Product Code
    NGE
    Regulation Number
    862.1485
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHEROMONE SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fertilité OV™ (PSC Fertility Monitor) is an over-the-counter ("OTC") in vitro diagnostic ("IVD") device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.
    Device Description
    The PSC Fertility Monitor consists of a small wristwatch that houses an interactive microprocessor and a biochemical sensor. The device measures chloride ion levels in female sweat from the skin surface in order to predict current fertility status by displaying the result on the screen. The device provides the user with notice up to four days before ovulation during which the user may have the greatest chance of becoming pregnant.
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