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

    GENERAL ELECTRIC AMX 110, AMX II AND AMX 3

    K Number: K944442 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    183

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    Basic Information

    Device Name
    GENERAL ELECTRIC AMX 110, AMX II AND AMX 3
    K Number
    K944442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro-Tronics, Inc.
    Date Received
    September 12, 1994
    Decision Date
    March 14, 1995
    Product Code
    IZL
    Advisory Committee
    Radiology
    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
    IZL System, X-Ray, Mobile

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    Other Clearances by Pro-Tronics, Inc.

    K Number Device Name
    K950971 MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
    K902610 GENERAL ELECTRIC AMX 3
    K891143 GENERAL ELECTRIC AMX 110
    K891142 GENERAL ELECTRIC AMX II