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

    GENERATOR, PULSE, IMPLANTABLE

    K Number: K770661 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    5
    Review Days
    19

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    Basic Information

    Device Name
    GENERATOR, PULSE, IMPLANTABLE
    K Number
    K770661
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Med Telectronics , Ltd.
    Date Received
    April 7, 1977
    Decision Date
    April 26, 1977
    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 Med Telectronics , Ltd.

    K Number Device Name
    K770282 WEDGE TIP, SMALL, MODEL #030-191
    K770284 BALL TIP, MODEL #030-185
    K770285 BALL TIP, MODEL #030-188
    K770283 WEDGE TIP, SMALL, MODEL #030-194