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

    EROS-CLITORAL THERAPY DEVICE (CTD)

    K Number: DEN000006 · Decision Apr 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    1

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    Basic Information

    Device Name
    EROS-CLITORAL THERAPY DEVICE (CTD)
    K Number
    DEN000006
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    884.5970
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Urometrics, Inc.
    Date Received
    April 27, 2000
    Decision Date
    April 28, 2000
    Product Code
    NBV
    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
    NBV Device, Engorgement, Clitoral

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