Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K083693
    Device Name
    PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
    Date Cleared
    2009-04-02

    (111 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 840 Ventilator System with Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (V- 5-2500 mL with NeoMode) or from infant to adult (V-25-2500 mL). The 840 Ventilator System with Leak Compensation is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
    Device Description
    The Leak Compensation Option enables the 840 Ventilator System to automatically detect and characterize gas flow that leaves the breathing circuit through air leak(s) and does not return to the 840's exhalation valve for inclusion in the displayed exhaled spirometry. LC does not makeup for lost delivered volume but does add the necessary additional flow into the breathing circuit to optimize breath triggering and cycling functions as well as maintain the set PEEP, and display clinically valuable leak-related parameters for consideration by the clinician. The Leak Compensation feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).
    Ask a Question
    K Number
    K082966
    Device Name
    PB 540 VENTILATOR
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
    Date Cleared
    2008-10-31

    (25 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician: - Positive Pressure ventilation - Assist/Control, SIMV, or CPAP modes of ventilation - Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.
    Device Description
    The PB 540 Ventilator gas delivery system is composed of a flow generator capable of supplying a sufficient range of flows and pressures that is then controlled by a three-way valve enabling piloting of the expiration valve. The flow generator is a low-inertia micro-turbine driven by a brushless electric motor and the valve is a proportional electronically driven valve. These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.
    Ask a Question

    Page 1 of 1