Search Results

The "TruMist™ Breath Actuated Disposable Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

TruMist Breath Actuated Disposable Nebulizer

This document is a 510(k) clearance letter from the FDA for a medical device called the "TruMist Breath Actuated Disposable Nebulizer." It essentially states that the device is substantially equivalent to a pre-existing legally marketed device and can therefore be marketed.

The document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance study methodology or results.

Ask a specific question about this device