EnsoSleep 01.1
EnsoSleep 01.1 is a Class II device made by Ensodata, Inc., cleared under FDA 510(k) K162627 on 31 Mar 2017 and listed in FDA GUDID since 19 Jul 2017 (UDI-DI 00864458000407), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | GUDID listing | Number00864458000407 | Date19 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162627 | Date31 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 00864458000407
- FDA 510(k) database K162627
Across registries
- FDA 510(k) K162627 decided 31 Mar 2017 Active
- FDA GUDID UDI-DI 00864458000407 listed 19 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K162627
- Listed FDA GUDID 00864458000407
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EnsoSleep
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 01.1
- Primary DI / UDI-DI
- 00864458000407
- 510(k) Number
- FDA product code
- OLZ
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- Not in Commercial Distribution
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