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510(k) Data Aggregation

    K Number
    K251615
    Device Name
    Aerogen Pro-X1 Controller System
    Manufacturer
    Aerogen Ltd
    Date Cleared
    2025-09-02

    (98 days)

    Product Code
    SFP
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aerogen® Pro-X1 controller System is a portable medical device system inclusive of the Aerogen Solo Nebulizer (Single-patient, Multiple use) which is intended to aerosolize prescribed medications for inhalation to paediatric (29 days and older) and adult patients during invasive ventilation, non-invasive respiratory support or to conscious and spontaneous breathing patients in the hospital environment.

    Device Description

    The Aerogen® Pro-X1 controller System is a portable medical device system inclusive of the Aerogen Solo Nebulizer (Single-patient, Multiple use) which is intended to aerosolize prescribed medications for inhalation to paediatric (29 days and older) and adult patients during invasive ventilation, non-invasive respiratory support or to conscious and spontaneous breathing patients in the hospital environment.

    AI/ML Overview

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