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

    RHYTHM WHEEL

    K Number: K813497 · Decision May 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    RHYTHM WHEEL
    K Number
    K813497
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Tropical Enterprises, Inc.
    Date Received
    December 14, 1981
    Decision Date
    May 3, 1982
    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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