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510(k) Data Aggregation

    K Number
    K200496
    Device Name
    Aer X
    Manufacturer
    Date Cleared
    2020-07-24

    (147 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    3B Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aer X oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Aer X may be used in home, institution, vehicle and various mobile environments.
    Device Description
    The Aer X oxygen concentrator utilies a molecular sieve and a differential pressure swing adsorption methodology to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94% in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it
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