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510(k) Data Aggregation

    K Number
    K021573
    Device Name
    PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
    Manufacturer
    PURITAN-BENNETT
    Date Cleared
    2002-08-13

    (91 days)

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

    PURITAN-BENNETT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 840 Ventilator with Volume Ventilation Plus™ Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The 840 Ventilator with Neomode and Volume Ventilation Plus™ Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options is intended for use in hospitals 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 VV+ modification provides the 840 Ventilator System with two new breath types, VC' and VS. The VV+ 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).
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    K Number
    K990897
    Device Name
    NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
    Manufacturer
    PURITAN-BENNETT IRELAND, LTD.
    Date Cleared
    2000-03-15

    (363 days)

    Product Code
    CAF, CBK
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN-BENNETT IRELAND, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.
    Device Description
    The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer. The nebulization functionality is implemented by: a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators. The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation. The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.
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