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

    KMI OXY-BAN

    K Number: K883848 · Decision Mar 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    171

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    Basic Information

    Device Name
    KMI OXY-BAN
    K Number
    K883848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Knight Medical, Inc.
    Date Received
    September 12, 1988
    Decision Date
    March 2, 1989
    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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