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

    NEUROPLUS, MODEL A10040, A10041, A10042, A10043

    K Number: K010638 · Decision May 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    NEUROPLUS, MODEL A10040, A10041, A10042, A10043
    K Number
    K010638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vermont Medical, Inc.
    Date Received
    March 5, 2001
    Decision Date
    May 3, 2001
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXY Electrode, Cutaneous

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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
    K921498 VER MED A10011 PNS DUAL ELEMENT ELECTRODE
    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