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510(k) Data Aggregation

    K Number
    K954183
    Device Name
    OVULATION CALCULATOR/CONCEPTION CALCULATOR
    Manufacturer
    HECTOR VIDES
    Date Cleared
    1996-02-29

    (176 days)

    Product Code
    MPT
    Regulation Number
    884.5350
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This is not a stand-alone device. It should be used in conjunction with your present contraceptive method.

    Device Description

    Ovulation Calculator

    AI/ML Overview

    I am sorry, but the provided text from the FDA letters for K954183 (Ovurite, Ovulation Calculator) does not contain information about the acceptance criteria for a study, performance data the device, sample sizes, ground truth establishment, or details of comparative effectiveness studies.

    The letters are primarily administrative communications from the FDA:

    • The July 11, 2022, letter is an administrative change notification regarding the device's regulation number.
    • The February 29, 1996, letter is the original substantial equivalence (SE) determination letter, which permits the device to be marketed as an accessory to a contraceptive method and specifies a required labeling statement ("This is not a stand-alone device. It should be used in conjunction with your present contraceptive method").

    Neither letter includes the detailed study information you've requested regarding device performance and validation.

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