BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM

    K Number: K032585 · Decision Jan 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    141

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    Basic Information

    Device Name
    TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
    K Number
    K032585
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ron-Tech Medical , Ltd.
    Date Received
    August 21, 2003
    Decision Date
    January 9, 2004
    Product Code
    HDC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDC Tenaculum, Uterine

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    Other Clearances by Ron-Tech Medical , Ltd.

    K Number Device Name
    K992071 TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE