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

    OXYBOX SYSTEM

    K Number: K023456 · Decision Feb 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    132

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    Basic Information

    Device Name
    OXYBOX SYSTEM
    K Number
    K023456
    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
    Oxyfast Corporation
    Date Received
    October 15, 2002
    Decision Date
    February 24, 2003
    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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