BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Mediracer NCS

    K Number: K190536 · Decision Sep 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    Mediracer NCS
    K Number
    K190536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediracer OY
    Date Received
    March 4, 2019
    Decision Date
    September 25, 2019
    Product Code
    JXE
    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
    JXE Device, Nerve Conduction Velocity Measurement

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