BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

    K Number: K014301 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    19
    Review Days
    42

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    Basic Information

    Device Name
    MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
    K Number
    K014301
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    December 31, 2001
    Decision Date
    February 11, 2002
    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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