BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    neuromate Gen III

    K Number: K181706 · Decision Jul 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    3
    Review Days
    28

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    Basic Information

    Device Name
    neuromate Gen III
    K Number
    K181706
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Renishaw Mayfield Sarl
    Date Received
    June 28, 2018
    Decision Date
    July 26, 2018
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Renishaw Mayfield Sarl

    K Number Device Name
    K180206 neuromate Gen III
    K132755 NEUROMATE FRAMELESS GEN II