Cerebra Sleep System 700014
Cerebra Sleep System 700014 is a Class II device made by Cerebra Medical, Ltd., cleared under FDA 510(k) K213007 on 6 Jul 2022 and listed in FDA GUDID since 13 Jul 2022 (UDI-DI B600700014), 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 | NumberB600700014 | Date13 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213007 | Date6 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K213007
Across registries
- FDA 510(k) K213007 decided 6 Jul 2022 Active
- FDA GUDID UDI-DI B600700014 listed 13 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K213007
- Listed FDA GUDID B600700014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cerebra Sleep System
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 700014
- Primary DI / UDI-DI
- B600700014
- 510(k) Number
- FDA product code
- OMC, OLV, OLZ
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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