BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    STIMPOD ST2-3010 NERVE STIMULATOR

    K Number: K140853 · Decision Nov 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    217

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    Basic Information

    Device Name
    STIMPOD ST2-3010 NERVE STIMULATOR
    K Number
    K140853
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xavant Technology (Pty), Ltd.
    Date Received
    April 3, 2014
    Decision Date
    November 6, 2014
    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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