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SomniCheck is a prescription-use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals: - · EEG (4-channel), - · PPG (by Maxim), - · Temperature, - · 3-axis accelerometer, - · Gyroscope (position), and - · Audio/ sound for snoring. It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

SomniCheck is an integrated single-use disposable physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. It is intended for adult use and can be used in a hospital, clinic, or patient home. The associated software There is proprietary software that is currently under development, but the subject device's signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing. The proprietary sleep software will be submitted in a future 510(k) Submission. The device is affixed to the forehead of the patient and designed for continuous wear (e.g. during sleep) for up to approximately 10 hours. Once activated, the device records data for the duration of the wear period. After the wear period, the device is removed and may be thrown away. The device measures the following signals: - · EEG (4-channel), - PPG (by Maxim®), - · Temperature, - · 3-axis accelerometer, - · Gyroscope (position), and - Audio/ sound for snoring.