ONE-WAY VALVE (WITH CONNECTOR)

• K Number: K970780
• Device Name: ONE-WAY VALVE (WITH CONNECTOR)
• Manufacturer: INSTRUMENTATION INDUSTRIES, INC.
• Date Cleared: 1997-09-18 ( 198 days)
• Product Code: CBP
• Regulation Number: 868.5870
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).