b075d99a-a072-405c-bcdd-f7053eb0a9bdUpdatePublished32026-03-092024-02-222025-04-07Not in Commercial Distribution00864458000445PrimaryGS1EnsoSleep PPG7.0080743964Ensodata, Inc.1Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or AurorafalsefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK23135500064938Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].falseActiveMNRVentilatory Effort Recorderfalsefalse