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

    STIMPOD MODEL NMS-400 NERVE STIMULATOR

    K Number: K093591 · Decision Dec 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    14

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    Basic Information

    Device Name
    STIMPOD MODEL NMS-400 NERVE STIMULATOR
    K Number
    K093591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xavant Technology (Pty), Ltd.
    Date Received
    November 19, 2009
    Decision Date
    December 3, 2009
    Product Code
    BXN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    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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    Other Clearances by Xavant Technology (Pty), Ltd.

    K Number Device Name
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    K110118 STIMTRODE SINGLE USE NERVE STIMULATOR
    K102084 STIMPOD NMS450 NERVE STIMULATOR
    K072092 XPOD/XMAP NERVE STIMULATOR