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

    OXITRON OXYGEN SENSOR

    K Number: K890144 · Decision May 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    OXITRON OXYGEN SENSOR
    K Number
    K890144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Oxitron Medical Products
    Date Received
    January 13, 1989
    Decision Date
    May 25, 1989
    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 Oxitron Medical Products

    K Number Device Name
    K890958 OXITRON OXYGEN ANALYZER