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

    TDK ECG ELECTRODE MEL-08

    K Number: K833899 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    TDK ECG ELECTRODE MEL-08
    K Number
    K833899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Tdk Corp.
    Date Received
    November 14, 1983
    Decision Date
    February 10, 1984
    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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    Other Clearances by Tdk Corp.

    K Number Device Name
    K883643 TDK ECG ELECTRODE, MEL-10L
    K882904 TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
    K870834 TDK ECG ELECTRODE MEL-10
    K863369 MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
    K854596 TDK ECG ELECTRODE MEL-08-09 & -11