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

    ELECTROCARDIOGRAPH ELECTRODE

    K Number: K801846 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    ELECTROCARDIOGRAPH ELECTRODE
    K Number
    K801846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Phoenix Glove Co.
    Date Received
    August 4, 1980
    Decision Date
    September 9, 1980
    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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