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

    MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

    K Number: K905403 · Decision Oct 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    34
    Review Days
    317

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    Basic Information

    Device Name
    MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
    K Number
    K905403
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cook Pacemaker Corp.
    Date Received
    December 3, 1990
    Decision Date
    October 16, 1991
    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 Cook Pacemaker Corp.

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    K970690 LOCKING STYLET 2
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    K953417 MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
    K915188 MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
    K863582 MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
    K861559 SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
    K860202 MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
    K860466 MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
    K854919 BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
    K854132 COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
    Search all 34 clearances from Cook Pacemaker Corp. →