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

    INSPIRATION VENTILATOR SYSTEM 5I/7I

    K Number: K130178 · Decision Oct 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    277

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    Basic Information

    Device Name
    INSPIRATION VENTILATOR SYSTEM 5I/7I
    K Number
    K130178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    eVent Medical, Ltd.
    Date Received
    January 25, 2013
    Decision Date
    October 29, 2013
    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 eVent Medical, Ltd.

    K Number Device Name
    K051550 INSPIRATION VENTILATOR SYSTEM
    K040220 MEDICAL AIR COMPRESSOR
    K030341 MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
    K021112 INSPIRATION VENTILATOR SYSTEM