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

    PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST

    K Number: K082237 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
    K Number
    K082237
    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
    August 7, 2008
    Decision Date
    October 9, 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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