BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

    K Number: K080966 · Decision Aug 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
    K Number
    K080966
    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
    Aoti , Ltd.
    Date Received
    April 4, 2008
    Decision Date
    August 6, 2008
    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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