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510(k) Data Aggregation

    K Number
    K051007
    Device Name
    ACCU02 SYSTEM
    Manufacturer
    MITI CORP.
    Date Cleared
    2005-06-16

    (57 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITI CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AccuO2 System, which provides oxygen therapy on demand, based on continuous, non-invasive monitoring of oxygen saturation, is indicated for home use by adult Chronic Obstructive Pulmonary Disease (COPD) patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal cannula and USP portable oxygen.
    Device Description
    The AccuO2 System is a portable, battery-operated system consisting of a proprietary demand oxygen delivery module combined with a commercially available pulse oximeter module. The system is used with a standard nasal cannula and USP portable oxygen. The proprietary software in the AccuO2 demand oxygen delivery module is designed to deliver oxygen on inhalation only and to maintain the patients at an oxygen saturation (SpO2) level of 90% while conserving oxygen.
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