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

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

    K Number: K230915 · Decision Nov 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    301
    Applicant Total
    7
    Review Days
    592

    Basic Information

    Device Name
    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
    K Number
    K230915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vyaire Medical, Inc.
    Date Received
    March 31, 2023
    Decision Date
    November 12, 2024
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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