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510(k) Data Aggregation

    K Number
    K202389
    Device Name
    Oxygen Concentrator
    Manufacturer
    Foshan MIC Medical Technology Co., LTD
    Date Cleared
    2022-04-08

    (595 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OXYGEN CONCENTRATOR is intended to provide supplemental oxygen in a home, institutional, or travel environment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for an Oxygen Concentrator. It does not contain any information about acceptance criteria, device performance, study details, human reader studies, or ground truth establishment relevant to an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

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