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

    LEKSELL NEURO GENERATOR AND ACCESSORIES

    K Number: K941823 · Decision Mar 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    709

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    Basic Information

    Device Name
    LEKSELL NEURO GENERATOR AND ACCESSORIES
    K Number
    K941823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elekta Instruments, Inc.
    Date Received
    April 13, 1994
    Decision Date
    March 22, 1996
    Product Code
    GXD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXD Generator, Lesion, Radiofrequency

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    Other Clearances by Elekta Instruments, Inc.

    K Number Device Name
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    K943468 LEKSELL SURGIPLAN
    K932261 ES-100 ACCESSORIES
    K925360 ES-100 POWER SYSTEM, ES-100 SERIES
    K914808 LEKSELL GAMMAPLAN (LGP)