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

    NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP

    K Number: K112634 · Decision Jul 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    298

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    Basic Information

    Device Name
    NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
    K Number
    K112634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inotec Amd , Ltd.
    Date Received
    September 9, 2011
    Decision Date
    July 3, 2012
    Product Code
    KPJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPJ Chamber, Oxygen, Topical, Extremity

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