BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    TELECTRONICS #030-253 BIFURCATED

    K Number: K831303 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    1
    Review Days
    34

    Basic Information

    Device Name
    TELECTRONICS #030-253 BIFURCATED
    K Number
    K831303
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    WILLIAM C. NEALON
    Date Received
    April 21, 1983
    Decision Date
    May 25, 1983
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

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