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

    CCD CAMERA, MODEL 9000

    K Number: K990066 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    16
    Review Days
    68

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    Basic Information

    Device Name
    CCD CAMERA, MODEL 9000
    K Number
    K990066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Camtronics, Ltd.
    Date Received
    January 8, 1999
    Decision Date
    March 17, 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 Camtronics, Ltd.

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