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

    CONTEC Oxygen Concentrator

    K Number: K180837 · Decision Jan 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    12
    Review Days
    286

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    Basic Information

    Device Name
    CONTEC Oxygen Concentrator
    K Number
    K180837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    March 30, 2018
    Decision Date
    January 10, 2019
    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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