BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    NERBRIDGE

    K Number: K152967 · Decision Jun 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    258

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    Basic Information

    Device Name
    NERBRIDGE
    K Number
    K152967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toyobo Co., Ltd.
    Date Received
    October 8, 2015
    Decision Date
    June 22, 2016
    Product Code
    JXI
    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
    JXI Cuff, Nerve

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