BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

    PMA: P210018 · Decision Mar 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
    Trade Name
    Et Control
    PMA Number
    P210018
    Device Class
    FDA Class 3
    Product Code
    QSF
    Generic Name
    Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2022
    Date Received
    May 3, 2021
    Expedited Review
    N
    Docket Number
    22M-0360

    Advisory Committee Statement

    Approval for Et Control indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The Et Control feature is indicated for patients, 18 years of age and older.The Aisys CS2 anesthesia system and the Et Control feature are intended for prescription use only.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSF Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents