Sensor Snore Embletta
Sensor Snore Embletta (P1718) is a Class II device made by Respironics Inc., cleared under FDA 510(k) K940015 on 11 Jan 1995 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00606959011236), 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 | Number00606959011236 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940015 | Date11 Jan 1995 | StatusActive |
Official records
- AccessGUDID record 00606959011236
- FDA 510(k) database K940015
Across registries
- FDA 510(k) K940015 decided 11 Jan 1995 Active
- FDA GUDID UDI-DI 00606959011236 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K940015
- Listed FDA GUDID 00606959011236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sensor
- Generic name
- Polysomnograph
- Model / Ref / Catalog
- Sensor Snore Embletta, P1718
- Primary DI / UDI-DI
- 00606959011236
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Polysomnograph
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Polysomnograph.