Sleepsense PS14841
by S. L. P. Scientific Laboratory Products Ltd
Sleepsense PS14841 is a Class II device made by S. L. P. Scientific Laboratory Products Ltd, cleared under FDA 510(k) K042253 on 6 Oct 2004 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 07290013385444), active as of 23 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 | Number07290013385444 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042253 | Date6 Oct 2004 | StatusActive |
Official records
- AccessGUDID record 07290013385444
- FDA 510(k) database K042253
Across registries
- FDA 510(k) K042253 decided 6 Oct 2004 Active
- FDA GUDID UDI-DI 07290013385444 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K042253
- Listed FDA GUDID 07290013385444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sleepsense
- Generic name
- Polysomnography analyser
- Model / reference
- PS14841
- Primary DI / UDI-DI
- 07290013385444
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Polysomnography analyser
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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