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

    VER MED A10011 PNS DUAL ELEMENT ELECTRODE

    K Number: K921498 · Decision Jun 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    435

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    Basic Information

    Device Name
    VER MED A10011 PNS DUAL ELEMENT ELECTRODE
    K Number
    K921498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vermont Medical, Inc.
    Date Received
    March 31, 1992
    Decision Date
    June 9, 1993
    Product Code
    BXM
    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
    BXM Stimulator, Nerve, Ac-Powered

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    Other Clearances by Vermont Medical, Inc.

    K Number Device Name
    K030073 VERMED A10021 RESTING EKG TAB ELECTRODE
    K021537 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
    K010638 NEUROPLUS, MODEL A10040, A10041, A10042, A10043
    K915831 THERMAL PROBE COVER
    K911687 VER-MED A10020 RESTING EKG ELECTRODE
    K910139 VER-MED A10014 RESTING EKG ELECTRODE & A10021
    K905489 VER-MED A10017 UNIVERSAL ELECTRODE
    K781430 PREGELLED DISPOSABLE E.K.G. ELECTRODE