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

    Nihon Kohden NKV-550 Series Ventilator System

    K Number: K181695 · Decision Dec 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    4
    Review Days
    163

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    Basic Information

    Device Name
    Nihon Kohden NKV-550 Series Ventilator System
    K Number
    K181695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden Orangemed, Inc.
    Date Received
    June 27, 2018
    Decision Date
    December 7, 2018
    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 Nihon Kohden Orangemed, Inc.

    K Number Device Name
    K222644 Nihon Kohden NKV-440 Ventilator System
    K213521 Nihon Kohden NKV-330 Ventilator System
    K192307 Nihon Kohden NKV-550 Series Ventilator System