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

    MEDI-TRACE 4103 NEONATAL ELECTRODE

    K Number: K981964 · Decision Nov 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    55
    Review Days
    162

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    Basic Information

    Device Name
    MEDI-TRACE 4103 NEONATAL ELECTRODE
    K Number
    K981964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Graphic Controls Corp.
    Date Received
    June 4, 1998
    Decision Date
    November 13, 1998
    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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