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The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liguids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.

The provided document is a 510(k) summary for the Hsiner Nebulizer Bottle. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Hsiner Jet Nebulizer K052811) rather than presenting a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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