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

    DATEX-OHMEDA INOVENT DELIVERY SYSTEM

    K Number: K000186 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    40
    Review Days
    27

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    Basic Information

    Device Name
    DATEX-OHMEDA INOVENT DELIVERY SYSTEM
    K Number
    K000186
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5165
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda
    Date Received
    January 14, 2000
    Decision Date
    February 10, 2000
    Product Code
    MRN
    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
    MRN Apparatus, Nitric Oxide Delivery

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