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The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.

The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.

The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.

This document is a 510(k) summary for the Skynector CPAP Mask, indicating substantial equivalence to predicate devices. It does not contain information about an AI-powered device or its acceptance criteria and studies as described in the prompt. The device is a medical instrument (CPAP mask) and the document focuses on its physical and performance characteristics compared to existing masks.

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