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

    DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM

    K Number: K950479 · Decision Sep 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    15
    Review Days
    222

    Basic Information

    Device Name
    DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
    K Number
    K950479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NIKOMED U.S.A., INC.
    Date Received
    February 3, 1995
    Decision Date
    September 13, 1995
    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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