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510(k) Data Aggregation

    K Number
    K051550
    Device Name
    INSPIRATION VENTILATOR SYSTEM
    Manufacturer
    EVENT MEDICAL LTD.
    Date Cleared
    2005-07-12

    (29 days)

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

    EVENT MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options 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 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 set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.
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