EnsoSleep PPG 8
EnsoSleep PPG 8 is a Class II device made by Ensodata, Inc., cleared under FDA 510(k) K231355 on 9 Feb 2024 and listed in FDA GUDID since 14 Apr 2025 (UDI-DI 00864458000469), 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 | GUDID listing | Number00864458000469 | Date14 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231355 | Date9 Feb 2024 | StatusActive |
Official records
- AccessGUDID record 00864458000469
- FDA 510(k) database K231355
Across registries
- FDA 510(k) K231355 decided 9 Feb 2024 Active
- FDA GUDID UDI-DI 00864458000469 listed 14 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K231355
- Listed FDA GUDID 00864458000469
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EnsoSleep PPG
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 8
- Primary DI / UDI-DI
- 00864458000469
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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