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510(k) Data Aggregation

    K Number
    K251764

    Validate with FDA (Live)

    Device Name
    Oxygen Concentrator-P2-O5E
    Manufacturer
    Qingdao Kingon Medical Science and Technology Co., Ltd.
    Date Cleared
    2025-12-22

    (196 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    18 - 150
    Reference & Predicate Devices
    K150930
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

    Device Description

    The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, fans, solenoid valves, molecular sieve beds, circuit control system, heat dissipation system, and a flow control device. Accessories include power cord, air intake filter box, air intake filter cotton.

    AI/ML Overview

    N/A

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