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510(k) Data Aggregation

    K Number
    K060265
    Device Name
    REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
    Manufacturer
    REMCORE, INC.
    Date Cleared
    2006-10-25

    (266 days)

    Product Code
    CAN
    Regulation Number
    868.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMCORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.
    Device Description
    Remcore Remote Control Oxygen Delivery System
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