BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Flight 60 Ventilator

    K Number: K143035 · Decision Mar 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    525

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    Basic Information

    Device Name
    Flight 60 Ventilator
    K Number
    K143035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flight Medical Innovations , Ltd.
    Date Received
    October 22, 2014
    Decision Date
    March 30, 2016
    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 Flight Medical Innovations , Ltd.

    K Number Device Name
    K223120 Ventoux VC2; Ventoux VC3
    K130171 FLIGHT 60 VENTILATOR
    K120726 FLIGHT 60 VENTILATOR
    K111683 FLIGHT 60 VENTILATOR