BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    DRY LASER IMAGER, MODEL DRYPRO MODEL 793

    K Number: K042133 · Decision Nov 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    27
    Review Days
    107

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    Basic Information

    Device Name
    DRY LASER IMAGER, MODEL DRYPRO MODEL 793
    K Number
    K042133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Konica Minolta Medical & Graphic, Inc.
    Date Received
    August 9, 2004
    Decision Date
    November 24, 2004
    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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