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510(k) Data Aggregation

    K Number
    K251661

    Validate with FDA (Live)

    Device Name
    Mariana Minerva; Mariana Nimbus
    Manufacturer
    Resmed Pty , Ltd.
    Date Cleared
    2026-02-23

    (269 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    K161492
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mariana Minerva is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.

    The Mariana Nimbus is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.

    Device Description

    The Mariana devices, that is Mariana Minerva and Mariana Nimbus, are non-invasive ventilation (NIV) devices that use a microprocessor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. They have an integrated alarms module. The Mariana devices also include optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The devices provide both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The devices use an external AC power supply and allow the addition of low pressure supplemental oxygen.

    AI/ML Overview

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