BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    CLAVIS

    K Number: K062478 · Decision Feb 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    1
    Review Days
    168

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    Basic Information

    Device Name
    CLAVIS
    K Number
    K062478
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtronic A/S
    Date Received
    August 24, 2006
    Decision Date
    February 8, 2007
    Product Code
    BXN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BXN Stimulator, Nerve, Battery-Powered

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