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The AeroChamber Z-STAT Plus™ Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be 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 document is a 510(k) premarket notification letter from the FDA to Traudell, Medical International for their Aerochamber Z-Stat Plus Valved Holding Chamber. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the given text.

To address your request, I would need a different type of document, such as a study report, clinical trial results, or a detailed product submission that outlines performance testing and acceptance criteria.

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