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The "AeroChamber® Plus Valved Holding Chamber 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 from most pressurized Metered Dose, Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "AeroChamber Plus™ Valved Holding Chamber." This document establishes the substantial equivalence of the device to legally marketed predicate devices and allows its marketing.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in the 510(k) submission itself, which is not provided here. The letter only refers to the submission and acknowledges its review.

Therefore, I cannot fulfill your request for details on acceptance criteria and study information based on the provided text. The document serves as a regulatory approval notice, not a technical report on device testing.

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