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

    EXL-14 MEDICAL LINEAR ACCELERATOR

    K Number: K880200 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    5
    Review Days
    206

    Basic Information

    Device Name
    EXL-14 MEDICAL LINEAR ACCELERATOR
    K Number
    K880200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    MITSUBISHI INTL. CORP.
    Date Received
    January 11, 1988
    Decision Date
    August 4, 1988
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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