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

    PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER

    K Number: K760766 · Decision Oct 8, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    6
    Review Days
    4

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    Basic Information

    Device Name
    PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER
    K Number
    K760766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Sweatman, Inc.
    Date Received
    October 4, 1976
    Decision Date
    October 8, 1976
    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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    Other Clearances by Fraser Sweatman, Inc.

    K Number Device Name
    K771299 EMERGENCY OXYGEN RESUSCITATOR
    K770911 MEDISHIELD JORDON LIFTING FRAME
    K770910 MEDISHIELD CERVICAL COLLAR
    K761140 FRASER SWEATMAN'S DOUBLE MASK
    K760076 ABSORBER, ANESTHESIA CIRCLE SYS, CO2