BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OXYGEN DELIVERY MEASURING DEVICE

    K Number: K851288 · Decision Sep 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    155

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    Basic Information

    Device Name
    OXYGEN DELIVERY MEASURING DEVICE
    K Number
    K851288
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2340
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bar-Dix, Inc.
    Date Received
    April 1, 1985
    Decision Date
    September 3, 1985
    Product Code
    CAX
    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
    CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated

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