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510(k) Data Aggregation

    K Number
    K122063
    Device Name
    INTELLISAVE AX700 ANESTHESIA SYSTEM
    Date Cleared
    2013-08-02

    (385 days)

    Product Code
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS ANESTHESIA CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intellisave AX700 Anesthesia System is intended to provide general inhalational anesthesia and ventilation support to neonatal, pediatric and adult patients. The device is intended to provide volume or pressure controlled ventilation.
    Device Description
    The Intellisave AX700 suitable for most types of inhalation anesthesia. O2 and N2O or O2 and Air can be administered, and anesthesia vaporizer(s) can be connected to a back bar. The gasses can be supplied from a centralized supply or cylinders. The Intellisave AX 700 is a prescriptive device restricted to use by, or on the order of, a physician. The Intellisave AX700 includes the following: An Electronic Gas Mixer (EGM), an anesthesia ventilator with various ventilation modes, an Integrated Breathing System (IBS), and an optional multigas module.
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