Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K972299
    Device Name
    BERGEN MODEL 500 ELECTROSURGERY GENERATOR
    Manufacturer
    BERGEN MFG.
    Date Cleared
    1997-08-27

    (69 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERGEN MFG.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
    Device Description
    An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.
    Ask a Question
    K Number
    K964736
    Device Name
    BERGEN 610 BIPOLAR COAGULATOR
    Manufacturer
    BERGEN MFG.
    Date Cleared
    1997-02-27

    (94 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERGEN MFG.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, full scale @ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
    Ask a Question

    Page 1 of 1