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

    PULSE GENERATOR MODEL 688

    K Number: K833519 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    10
    Review Days
    111

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    Basic Information

    Device Name
    PULSE GENERATOR MODEL 688
    K Number
    K833519
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Burditt & Calkins-Siemens-Elema
    Date Received
    October 11, 1983
    Decision Date
    January 30, 1984
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Burditt & Calkins-Siemens-Elema

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    K803111 ERECTAID
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