(113 days)
This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used by patients who require aerosolized medications. It provides additional hydration to help loosen secretions for patients whose condition is such that superior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. It is intended for use with bronchodilators, corticosteroids, antibiotics, mucolytics, and diagnostic formulations.
HOPE Nebulizer
The provided document is a 510(k) premarket notification letter from the FDA for the "Hope Nebulizer II". It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about such studies. It is a regulatory approval letter, not a study report or technical specification document.
Therefore, I cannot provide the requested information based solely on the text provided.
§ 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).