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

    AVEA VENTILATOR

    K Number: K062093 · Decision Sep 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    58

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    Basic Information

    Device Name
    AVEA VENTILATOR
    K Number
    K062093
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viasys Respiratory Care, Inc.
    Date Received
    July 24, 2006
    Decision Date
    September 20, 2006
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Viasys Respiratory Care, Inc.

    K Number Device Name
    K100928 MICRO DIARY SPIROMETER
    K073069 MODIFICATION TO AVEA VENTILATOR