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# Beacon Biosignals 510(k) for Sleep Monitor
- URL: https://www.fdaweb.com/beacon-biosignals-510-k-for-sleep-monitor/
- Published: 2023-09-15T12:00:00.000Z
- Updated: 2026-09-14T18:56:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155344

FDA has cleared a Beacon Biosignals [510(k)](https://www.accessdata.fda.gov/cdrh%5Fdocs/pdf22/K223539.pdf?ref=fdaweb.com) for the Dreem 3S, a wearable headband with integrated machine-learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. The device allows patients to participate in clinically validated, EEG-based sleep monitoring at home to evaluate sleep physiology, according to the company. The Dreem 3S is designed to record for a 24-hour duration, is equipped with six electrodes and has an integrated accelerometer to measure head movement and body position, the company says.