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Bio-logic gets 510(k) for Sleepscan

This article was originally published in Clinica

Executive Summary

Bio-logic Systems has received 510(k) clearance from the US FDA to market Sleepscan Traveler, its ambulatory polysomnography system. The device is a miniaturised computer which records physiological activity - oximetry, heart rate, body position, air flow, EEG, ECG and EMG - used in the diagnosis of sleep disorders such as sleep apnoea and is intended for use in the home.

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