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

    MEDTRONIC SULLIVAN NASAL CPAP SYSTEM

    K Number: K905404 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    475
    Review Days
    161

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    Basic Information

    Device Name
    MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
    K Number
    K905404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Vascular
    Date Received
    December 3, 1990
    Decision Date
    May 13, 1991
    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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