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510(k) Data Aggregation

    K Number
    K081267
    Device Name
    HYGEIA-5 OXYGEN CONCENTRATOR
    Date Cleared
    2008-09-23

    (141 days)

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

    KEDL INTERNATION LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The Hygeia-5 Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device operates on the same pressure swing adsorption (PSA) principle as other oxygen concentrators. They use the same type of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. Most concentrators use two sieve beds, alternating between the beds using one bed to generate the oxygen while the other is flushed for regeneration. The Hygeia-5 differs in as much as it has 5 smaller beds instead of two large beds and uses a rotating valve to distribute the air to the sieve beds and control the cycle of the adsorption and regeneration. This concept/design is similar to the Sequal device. As with other concentrators, it has an Oxygen reservoir to collect the oxygen before distribution to the patient. The Oxygen concentrator is also equipped with electronic alarms to monitor for power failure and over or under pressure of the pneumatic system.
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