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

    AMERICAN BANTEX MS 4 MINI SCOOTER

    K Number: K040754 · Decision Jul 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    AMERICAN BANTEX MS 4 MINI SCOOTER
    K Number
    K040754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Bantex Corp.
    Date Received
    March 24, 2004
    Decision Date
    July 23, 2004
    Product Code
    INI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    INI Vehicle, Motorized 3-Wheeled

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    Other Clearances by American Bantex Corp.

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    K031711 TANGO, MODELS, BP1
    K963218 BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE