Neurology
EnsoSleep
EnsoData, Inc.
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
FDA Submission Metadata
- Submission number
- K210034
- Decision date
- June 2021
- FDA panel
- Neurology
- Product code
- OLZ
- Clinical task (npj)
- detection/diagnosis
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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