BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OVULATION CALCULATOR/CONCEPTION CALCULATOR

    K Number: K954183 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    176

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    Basic Information

    Device Name
    OVULATION CALCULATOR/CONCEPTION CALCULATOR
    K Number
    K954183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5350
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hector Vides
    Date Received
    September 6, 1995
    Decision Date
    February 29, 1996
    Product Code
    MPT
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPT Contraception Calculator