BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    GOODKNIGHT H20, MODEL M-114600-00

    K Number: K042184 · Decision Jan 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    7
    Review Days
    151

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    Basic Information

    Device Name
    GOODKNIGHT H20, MODEL M-114600-00
    K Number
    K042184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Developpement France
    Date Received
    August 12, 2004
    Decision Date
    January 10, 2005
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Mallinckrodt Developpement France

    K Number Device Name
    K082237 PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
    K080439 SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
    K071575 SANDMAN INTRO
    K063501 KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
    K041819 GOODKNIGHT 425, MODELM-114500-00
    K001845 MALLINCKRODT, GOODKNIGHT 418S