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

    OVU-TRAC OVULATION TIMING KIT

    K Number: K870528 · Decision May 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    OVU-TRAC OVULATION TIMING KIT
    K Number
    K870528
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Ob/Gyn Concepts, Ltd.
    Date Received
    February 5, 1987
    Decision Date
    May 6, 1987
    Product Code
    LHD
    Advisory Committee
    Unknown
    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
    LHD Device, Fertility Diagnostic, Proceptive

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    Other Clearances by Ob/Gyn Concepts, Ltd.

    K Number Device Name
    K863610 THE OB-GYN CONCEPTS VAGINAL ASPIRATOR