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

    SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

    K Number: K031649 · Decision Dec 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    191

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    Basic Information

    Device Name
    SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
    K Number
    K031649
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fink Engineering Pty, Ltd.
    Date Received
    May 28, 2003
    Decision Date
    December 5, 2003
    Product Code
    CBF
    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
    CBF Chamber, Hyperbaric

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