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

    NELLCOR PURITAN BENNETT, GOODKNIGHT 418G

    K Number: K991150 · Decision Apr 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    2
    Review Days
    8

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    Basic Information

    Device Name
    NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
    K Number
    K991150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett France Dvpt.
    Date Received
    April 6, 1999
    Decision Date
    April 14, 1999
    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
    K993584 MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2