EnsoSleep
510(k) K210034
EnsoSleep is a Class II device made by Ensodata, Inc., cleared under FDA 510(k) K210034 on 16 Jun 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210034 | Date16 Jun 2021 | StatusActive |
Official records
- FDA 510(k) database K210034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K210034
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EnsoSleep 7.0 | 7.0 | 00864458000414 | — | No longer on the market |
| EnsoSleep 8 | 8 | 00864458000476 | — | On the market |
Similar devices
Other devices filed under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).
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- Sleepware G3 by Respironics, Inc.
- Sleep Analysis Module by Neurotronics, LLC
- NEAT 001 by Brain Electrophysiology Laboratory Company, LLC
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