(474 days)
The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.
The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anesthesia. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.
This document is a 510(k) summary for the Servo Guard bacterial and viral filter. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the format requested. The document describes the device, its intended use, and claims substantial equivalence to predicate devices, but lacks details on performance studies with specific statistical metrics.
Therefore, I cannot extract the requested information from the provided text.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).