BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

    K Number: K011435 · Decision Jun 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
    K Number
    K011435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hmt, Inc.
    Date Received
    May 10, 2001
    Decision Date
    June 22, 2001
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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