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

    STIMUPLEX-DIG-RC NERVE STIMULATOR

    K Number: K021033 · Decision Mar 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    149
    Review Days
    357

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    Basic Information

    Device Name
    STIMUPLEX-DIG-RC NERVE STIMULATOR
    K Number
    K021033
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    March 29, 2002
    Decision Date
    March 21, 2003
    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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