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510(k) Data Aggregation

    K Number
    K113743
    Device Name
    EVOLUTION 3E VENTILATOR
    Manufacturer
    EVENT MEDICAL, INC.
    Date Cleared
    2012-12-18

    (364 days)

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

    EVENT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues. This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 lb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician. The eVolution 3e ventilator system is a class IIb medical device to be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.
    Device Description
    The eVolution 3e Ventilator utilizes dual valve technology and three hot wire flow sensors for precise breath delivery and lower work of breathing. The eVolution 3e is an electrically powered microprocessor-controlled software-driven ventilator with an electrically controlled exhalation valve. The eVolution 3e is available in two configurations; one version of The eVolution 3e utilizes an integrated high performance internal gas source (blower) and the second version of the eVolution 3e utilizes outside compressed air source and does not utilize a blower.
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    K Number
    K072590
    Device Name
    INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
    Manufacturer
    EVENT MEDICAL, INC.
    Date Cleared
    2008-01-04

    (112 days)

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

    EVENT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
    Device Description
    The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture. This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.
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