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

    NOVOX OXYGEN ANALYZER 400

    K Number: K840392 · Decision Feb 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    NOVOX OXYGEN ANALYZER 400
    K Number
    K840392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    January 30, 1984
    Decision Date
    February 27, 1984
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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