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510(k) Data Aggregation

    K Number
    K200401
    Device Name
    Apogee
    Manufacturer
    Incoba Ltd. d/b/a Dynaris
    Date Cleared
    2020-11-14

    (270 days)

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

    Incoba Ltd. d/b/a Dynaris

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.
    Device Description
    The proposed device, Apogee, senses each nostril independently through a bifurcated cannula and responds to the dynamic changes in nasal air-flow making a breath-to-breath determination of where to deliver the next bolus of oxygen: to the left, the right, or both nostrils. The Apogee Device is composed of the main components as detailed below: Control Unit, Control Board (Regulated Voltage Supply), Embedded Processor, User supplied Demand Cannula, The Apogee Bypass Cannula and Restrictor and Cylinder Tubing.
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