Michele Sleep Scoring System 1
Michele Sleep Scoring System 1 is a Class II device made by Cerebra Medical, Ltd., cleared under FDA 510(k) K112102 on 20 Dec 2011 and listed in FDA GUDID since 12 Feb 2018 (UDI-DI B6005537160), 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 | NumberB6005537160 | Date12 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112102 | Date20 Dec 2011 | StatusActive |
Official records
- FDA 510(k) database K112102
Across registries
- FDA 510(k) K112102 decided 20 Dec 2011 Active
- FDA GUDID UDI-DI B6005537160 listed 12 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K112102
- Listed FDA GUDID B6005537160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Michele Sleep Scoring System
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 1
- Primary DI / UDI-DI
- B6005537160
- 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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