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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

    K Number: K213825 · Decision Apr 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    14
    Review Days
    506

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    Basic Information

    Device Name
    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
    K Number
    K213825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Received
    December 8, 2021
    Decision Date
    April 28, 2023
    Product Code
    CAW
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAW Generator, Oxygen, Portable

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