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

    DIAMED MODELS 600, 900, 960, 964

    K Number: K854953 · Decision Apr 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    7
    Review Days
    133

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    Basic Information

    Device Name
    DIAMED MODELS 600, 900, 960, 964
    K Number
    K854953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Diamed Division Ill. Tool Works, Inc.
    Date Received
    December 10, 1985
    Decision Date
    April 22, 1986
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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