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

    PERCENT OXYGEN SENSOR

    K Number: K952736 · Decision Oct 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    119
    Applicant Total
    3
    Review Days
    125

    Basic Information

    Device Name
    PERCENT OXYGEN SENSOR
    K Number
    K952736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ANALYTICAL INDUSTRIES, INC.
    Date Received
    June 15, 1995
    Decision Date
    October 18, 1995
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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    Other Clearances by ANALYTICAL INDUSTRIES, INC.

    K Number Device Name
    K053407 OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
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