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

    PACEMAKER, OVALITH-D CARDIAC

    K Number: K790566 · Decision Mar 19, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    1
    Review Days
    —

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    Basic Information

    Device Name
    PACEMAKER, OVALITH-D CARDIAC
    K Number
    K790566
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Caratomic
    Date Received
    March 19, 1979
    Decision Date
    March 19, 1979
    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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