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The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.

The NIVO Nebuliser System is suitable for use in adult and pediatric 7 years or older (>20kg) patients whilst using a facemask.

The Aeroneb® Pro X control module, cables, adaptor and bracket components of the NIVO Nebuliser system are intended for multiple patient use as described in the instruction manual.

The NIVO Nebuliser unit, EE and SE elbow components of the NIVO Nebuliser system are intended for single use as described in the instruction manual.

The NIVO Nebuliser System is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance. The system includes the Aeroneb® Pro X control module, cables, adaptor and bracket components (intended for multiple patient use) and the NIVO Nebuliser unit, EE and SE elbow components (intended for single use).

The provided text is a medical device approval letter from the FDA for the VIVO Nebulizer System, dated November 10, 2010. It focuses on the device's substantial equivalence to previously marketed devices and its regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot provide an answer based on the given text.

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