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

    UNIFOCAL 3

    K Number: K810121 · Decision Feb 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    14
    Review Days
    35

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    Basic Information

    Device Name
    UNIFOCAL 3
    K Number
    K810121
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Pacemaker Corp.
    Date Received
    January 19, 1981
    Decision Date
    February 23, 1981
    Product Code
    DXY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    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 American Pacemaker Corp.

    K Number Device Name
    K821791 EXTERNAL PULSE GENERATOR - EV4542
    K812830 APC IMPLANTABLE PACING LEAD
    K812807 APC IMPLANTABLE PACING LEADS
    K810397 APC IMPLANTABLE PACING LEAD-FLANGE #3260
    K810396 APC IMPLANTABLE PACING LEAD, TINED #3262
    K810398 APC IMPLANTABLE PACING LEAD, MODEL 3266
    K810399 APC IMPLANTABEL PACING LEAD, MODEL 3264
    K800746 UNIFOCAL VP, MODELS 7501 AND 7502
    K800379 BIFOCAL 2 8200 SERIES (A,B C,D)
    K791955 UNIFOCAL 1 UNIPOLAR DEMAND R WAVE
    Search all 14 clearances from American Pacemaker Corp. →