BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    VIVO 50

    K Number: K123144 · Decision Jun 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    256

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    Basic Information

    Device Name
    VIVO 50
    K Number
    K123144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare, Breas Medical AB
    Date Received
    October 5, 2012
    Decision Date
    June 18, 2013
    Product Code
    NOU
    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
    NOU Continuous, Ventilator, Home Use

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