BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    TENZING SYSTEM

    K Number: K102130 · Decision Aug 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    TENZING SYSTEM
    K Number
    K102130
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mazor Surgical Technologies , Ltd.
    Date Received
    July 29, 2010
    Decision Date
    August 26, 2010
    Product Code
    HAW
    Advisory Committee
    Neurology
    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
    HAW Neurological Stereotaxic Instrument

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