BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    BIPAP FOCUS

    K Number: K053168 · Decision Jan 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    51

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    Basic Information

    Device Name
    BIPAP FOCUS
    K Number
    K053168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics (Ireland) Limited
    Date Received
    November 14, 2005
    Decision Date
    January 4, 2006
    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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