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The SIMPLIFY COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The SIMPLIFY COMPACT RESUSCITATOR provided in reusable models and in the disposable models.

manual resuscitators incorporating a bag and valve

The provided document is a 510(k) premarket notification letter from the FDA to Polymed (Xiamen) Plastic Industrial Company, Limited regarding their Simplify Compact Resuscitator. This document is primarily an approval letter and does not contain the detailed study information, acceptance criteria, or performance data that would allow me to answer your request thoroughly.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for marketing based on its similarity to existing devices, but the letter does not include the specific scientific study or acceptance criteria details you are asking for.

To address your request, I would need a different type of document, such as the full 510(k) submission, a clinical trial report, or a comprehensive device performance study.

Therefore, I cannot provide the requested information based on the given input.

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