BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LINEAR ACCELERATOR THERAC 25

    K Number: K837347 · Decision Jun 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    LINEAR ACCELERATOR THERAC 25
    K Number
    K837347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Atomic Energy of Canada
    Date Received
    April 4, 1983
    Decision Date
    June 24, 1983
    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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