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

    MAGNATRODE CARDIAC MONITORING ELECTRODE

    K Number: K832516 · Decision Dec 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    9
    Review Days
    141

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    Basic Information

    Device Name
    MAGNATRODE CARDIAC MONITORING ELECTRODE
    K Number
    K832516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    R2 Corp.
    Date Received
    July 28, 1983
    Decision Date
    December 16, 1983
    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 R2 Corp.

    K Number Device Name
    K800937 R2 PLATE TYPE CABLE-ADAPTOR #S 175,176
    K800930 R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.
    K800936 R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171
    K800932 ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120
    K800931 R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
    K800935 R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
    K800934 R2 ESU CABLE-ADAPTER MODELS 160,161
    K800933 R2 ELECTROSURG. RETURN ELECT. #225ETC.