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

    VERMED A10021 RESTING EKG TAB ELECTRODE

    K Number: K030073 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    VERMED A10021 RESTING EKG TAB ELECTRODE
    K Number
    K030073
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vermont Medical, Inc.
    Date Received
    January 8, 2003
    Decision Date
    March 28, 2003
    Product Code
    DRX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRX Electrode, Electrocardiograph

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    Other Clearances by Vermont Medical, Inc.

    K Number Device Name
    K021537 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
    K010638 NEUROPLUS, MODEL A10040, A10041, A10042, A10043
    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