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

    PROGRAMMABLE STIMULATOR 5326

    K Number: K843718 · Decision Sep 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    475
    Review Days
    3

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    Basic Information

    Device Name
    PROGRAMMABLE STIMULATOR 5326
    K Number
    K843718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Vascular
    Date Received
    September 24, 1984
    Decision Date
    September 27, 1984
    Product Code
    JOQ
    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
    JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

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