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

    PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL

    K Number: K945682 · Decision Feb 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    14
    Review Days
    80

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    Basic Information

    Device Name
    PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
    K Number
    K945682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gendex Corp.
    Date Received
    November 21, 1994
    Decision Date
    February 9, 1995
    Product Code
    EGY
    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
    EGY Processor, Radiographic-Film, Automatic, Dental

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