(82 days)
The Quixie is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or healthcare professional. The intended environments for use include the home, hospitals, and clinics. The Quixie is intended for multiple use by a single patient.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the Quixie Nebulizer does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a letter confirming the substantial equivalence of the Quixie Nebulizer to a legally marketed predicate device, allowing it to be marketed. It focuses on regulatory aspects such as classification, general controls, and compliance with the Act, rather than detailing the results of performance studies or specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given input.
§ 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).