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

    KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER

    K Number: K951807 · Decision Sep 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
    K Number
    K951807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kodak Health Imaging Systems, Inc.
    Date Received
    April 19, 1995
    Decision Date
    September 13, 1995
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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