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

    SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

    K Number: K080439 · Decision May 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
    K Number
    K080439
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Developpement France
    Date Received
    February 19, 2008
    Decision Date
    May 16, 2008
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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    Other Clearances by Mallinckrodt Developpement France

    K Number Device Name
    K082237 PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
    K071575 SANDMAN INTRO
    K063501 KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
    K042184 GOODKNIGHT H20, MODEL M-114600-00
    K041819 GOODKNIGHT 425, MODELM-114500-00
    K001845 MALLINCKRODT, GOODKNIGHT 418S