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

    AFP 17 X 4 AUTOMATIC FILM PROCESSOR

    K Number: K925885 · Decision Jun 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    13
    Review Days
    205

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    Basic Information

    Device Name
    AFP 17 X 4 AUTOMATIC FILM PROCESSOR
    K Number
    K925885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Afp Imaging Corp.
    Date Received
    November 16, 1992
    Decision Date
    June 9, 1993
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

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