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The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.

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The provided text describes a 510(k) premarket notification for a medical device called the "Res-Q Continuous Nebulizer." This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These details are typically found in the scientific documentation submitted as part of the 510(k) application, which is not included in this letter.

Therefore, I cannot provide the requested information based on the provided text.

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