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

    OXITRON OXYGEN ANALYZER

    K Number: K890958 · Decision May 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    2
    Review Days
    84

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OXITRON OXYGEN ANALYZER
    K Number
    K890958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Oxitron Medical Products
    Date Received
    February 27, 1989
    Decision Date
    May 22, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CCL), ordered by most recent decision date.

    OxyMinder Pro (10310)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Smart Check O2 (MA0236)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Maxtec MaxO2 ME+p

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Percent Oxygen Sensors

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OxyMinder

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Accu O2 Oxygen Analyzer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Oxitron Medical Products

    K Number Device Name
    K890144 OXITRON OXYGEN SENSOR