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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

    K Number: K053230 · Decision May 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    19
    Review Days
    179

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    Basic Information

    Device Name
    MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
    K Number
    K053230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    November 18, 2005
    Decision Date
    May 16, 2006
    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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