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Uni-directional valve to prevent back flow of gas in unintended, reverse direction

The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where "back flow" must be avoided. They are designed to prevent the flow of gas back toward the source.

The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where "back flow" must be avoided. They are designed to prevent the flow of gas back toward the source.

This document is a 510(k) clearance letter from the FDA for a medical device called the "BE 130 Series One-Way Valves." It does not contain information about acceptance criteria or a study proving device performance in the way requested.

Specifically, the document focuses on:

• The FDA's determination of substantial equivalence for the device.
• Regulatory class and product codes.
• General controls provisions of the Act.
• Contact information for compliance and assistance.
• Device indication for use and a brief summary of its function.

Therefore, I cannot provide the requested information from this document. This document is a regulatory approval notice, not a study report detailing performance metrics.

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