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

    OXYGEN FLOW CONTROLLER

    K Number: K920783 · Decision Sep 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    8
    Applicant Total
    110
    Review Days
    211

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    Basic Information

    Device Name
    OXYGEN FLOW CONTROLLER
    K Number
    K920783
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2300
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritan Bennett Corp.
    Date Received
    February 20, 1992
    Decision Date
    September 18, 1992
    Product Code
    CCN
    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
    CCN Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge

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