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

    PREGELLED INFANT DISPOSABLE ECG ELECTRODE

    K Number: K862756 · Decision Aug 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    26
    Review Days
    15

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    Basic Information

    Device Name
    PREGELLED INFANT DISPOSABLE ECG ELECTRODE
    K Number
    K862756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Labeltape Meditect, Inc.
    Date Received
    July 22, 1986
    Decision Date
    August 6, 1986
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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