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510(k) Data Aggregation

    K Number
    K052244
    Device Name
    IISIS, VERSION 1.0
    Manufacturer
    INNOVISION MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2005-10-13

    (57 days)

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

    INNOVISION MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IISIS is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station and to provide remote monitoring and alarm surveillance. IISIS is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    IISIS software provides continuous display of ventilator data at a central station and remote workstations. IISIS utilizes wireless technology to interface with most critical care and home care ventilators that have RS-232, Ethernet, or nurse call. IISIS is accessed and displays ventilator data and waveforms through web-based technology. IISIS provides real-time alarm annunciation, displays and stores ventilator settings, parameters, and ventilator waveforms as a secondary tool to the primary ventilator alarm and data display.
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