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

    ELECTRODE TESTER

    K Number: K780501 · Decision May 19, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    52

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    Basic Information

    Device Name
    ELECTRODE TESTER
    K Number
    K780501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mg Medical Electronics
    Date Received
    March 28, 1978
    Decision Date
    May 19, 1978
    Product Code
    KRC
    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
    KRC Tester, Electrode, Surface, Electrocardiographic

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