BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR

    K Number: K892841 · Decision Oct 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    170

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    Basic Information

    Device Name
    BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
    K Number
    K892841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bedfont Technical Instruments , Ltd.
    Date Received
    April 18, 1989
    Decision Date
    October 5, 1989
    Product Code
    CCJ
    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
    CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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