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

    NEURO N 50 LESION GENERATOR

    K Number: K896450 · Decision Mar 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    495

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    Basic Information

    Device Name
    NEURO N 50 LESION GENERATOR
    K Number
    K896450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Leibinger & Fischer , Ltd.
    Date Received
    November 9, 1989
    Decision Date
    March 19, 1991
    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 Leibinger & Fischer , Ltd.

    K Number Device Name
    K892425 STP COMPLETE MODULE SET