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

    SIEMENS MEVATRON ME

    K Number: K852907 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    13
    Review Days
    72

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    Basic Information

    Device Name
    SIEMENS MEVATRON ME
    K Number
    K852907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Medical Laboratories, Inc.
    Date Received
    July 9, 1985
    Decision Date
    September 19, 1985
    Product Code
    LHN
    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
    LHN System, Radiation Therapy, Charged-Particle, Medical

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