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

    UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

    K Number: K852973 · Decision Mar 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    43
    Review Days
    259

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    Basic Information

    Device Name
    UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
    K Number
    K852973
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ela Medical, Inc.
    Date Received
    July 15, 1985
    Decision Date
    March 31, 1986
    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 Ela Medical, Inc.

    K Number Device Name
    K042002 SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
    K032466 SPIDERVIEW
    K002817 SYNETEC
    K993448 STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
    K000029 STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
    K990727 SYNEFLASH & SYNEVIEW
    K972574 STELA MODEL UJ45 PACING LEADS
    K970072 OPUS S MODEL 4121 AND 4124 PACEMAKERS
    K963738 STELA MODEL BJ44 AND BJ45 PACING LEADS
    K952364 OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
    Search all 43 clearances from Ela Medical, Inc. →