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

    ELK LASER FILM DIGITIZER

    K Number: K984409 · Decision Feb 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    65

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    Basic Information

    Device Name
    ELK LASER FILM DIGITIZER
    K Number
    K984409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nishimoto Sangyo Co., Ltd.
    Date Received
    December 9, 1998
    Decision Date
    February 12, 1999
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

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    Other Clearances by Nishimoto Sangyo Co., Ltd.

    K Number Device Name
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