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

    THE M100 AIR/OXYGEN MIXER

    K Number: K860373 · Decision May 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    22
    Review Days
    107

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    Basic Information

    Device Name
    THE M100 AIR/OXYGEN MIXER
    K Number
    K860373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    February 3, 1986
    Decision Date
    May 21, 1986
    Product Code
    BZR
    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
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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