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

    EKG ELECTRODES, DISPOSABLE

    K Number: K781940 · Decision Nov 29, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    5
    Review Days
    9

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    Basic Information

    Device Name
    EKG ELECTRODES, DISPOSABLE
    K Number
    K781940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hayes Products, Inc.
    Date Received
    November 20, 1978
    Decision Date
    November 29, 1978
    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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