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

    DRYSTAR 4500 PRINTER, MODEL 4500

    K Number: K010275 · Decision Apr 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    DRYSTAR 4500 PRINTER, MODEL 4500
    K Number
    K010275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Agfa Medical Imaging
    Date Received
    January 30, 2001
    Decision Date
    April 27, 2001
    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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