(60 days)
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
The provided text is a 510(k) premarket notification letter from the FDA regarding the Aeroneb® Professional Nebulizer System. This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the detailed technical documentation submitted as part of the 510(k) application, a summary of which might be included in the "510(k) Summary" document, but not in this specific letter.
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§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).