BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MiniStim MS-IVB Peripheral Nerve Stimulator

    K Number: K143095 · Decision Mar 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    147

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    Basic Information

    Device Name
    MiniStim MS-IVB Peripheral Nerve Stimulator
    K Number
    K143095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Halyard Health, Inc.
    Date Received
    October 28, 2014
    Decision Date
    March 24, 2015
    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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