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

    COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED

    K Number: K911750 · Decision Oct 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    6
    Review Days
    180

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    Basic Information

    Device Name
    COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED
    K Number
    K911750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Instrumentation & Diagnostics Corp.(Midco)
    Date Received
    April 18, 1991
    Decision Date
    October 15, 1991
    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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    K921740 COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED
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