BEUDAMED
    Product Code: MPT FDA class 2 21 CFR 884.5350

    Contraception Calculator

    Obstetrics/Gynecology

    The Contraception Calculator is an obstetrics/gynecology device used to help women estimate their fertile window and predict low-risk days for unprotected intercourse based on menstrual cycle data, serving as a rhythm-method or fertility-awareness aid. Classified as FDA Class 2 under 21 CFR 884.5350, it requires 510(k) premarket notification. The product code is MPT.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MPT
    Device Class
    FDA class 2
    Regulation Number
    884.5350
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K954183 OVULATION CALCULATOR/CONCEPTION CALCULATOR