Watch-PAT200U Ventilatory Effort Recorder

The Watch-PAT200U is a ventilatory effort recorder, designed to monitor respiratory effort and sleep-related breathing patterns. It utilises patented technology to detect apnoeas, hypopnoeas, and other respiratory events by measuring changes in peripheral arterial tone and body position. This non-invasive device is primarily used in the assessment of sleep-disordered breathing, including obstructive sleep apnoea (OSA).

The Watch-PAT200U is supplied as a reusable medical device and is intended for use in clinical settings such as sleep laboratories or home monitoring environments. It operates without the need for MRI compatibility and is classified as a Class II device under FDA regulations. The device requires calibration and maintenance as specified in its operational manuals. Authorisation for this device includes an FDA 510(k) clearance under the advisory committee for Anesthesiology, with a decision date of February 24, 2017.