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

    MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2

    K Number: K993584 · Decision Mar 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    2
    Review Days
    137

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    Basic Information

    Device Name
    MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
    K Number
    K993584
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett France Dvpt.
    Date Received
    October 22, 1999
    Decision Date
    March 7, 2000
    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 Nellcor Puritan Bennett France Dvpt.

    K Number Device Name
    K991150 NELLCOR PURITAN BENNETT, GOODKNIGHT 418G