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

    SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

    K Number: K974417 · Decision Jun 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    212

    Basic Information

    Device Name
    SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
    K Number
    K974417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RESMED CORP.
    Date Received
    November 24, 1997
    Decision Date
    June 24, 1998
    Product Code
    MNS
    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
    MNS Ventilator, Continuous, Non-Life-Supporting

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