Be Plus Ltm B9700082000
by Eb Neuro SpA
Be Plus Ltm B9700082000 is a Class II device made by Eb Neuro SpA, cleared under FDA 510(k) K121996 on 3 Aug 2012 and listed in FDA GUDID since 24 May 2019 (UDI-DI 08056446900086), 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 | Number08056446900086 | Date24 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121996 | Date3 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 08056446900086
- FDA 510(k) database K121996
Across registries
- FDA 510(k) K121996 decided 3 Aug 2012 Active
- FDA GUDID UDI-DI 08056446900086 listed 24 May 2019 Listed
Timeline
- Cleared FDA 510(k) K121996
- Listed FDA GUDID 08056446900086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Be Plus Ltm
- Generic name
- Electroencephalograph
- Model / reference
- B9700082000
- Primary DI / UDI-DI
- 08056446900086
- 510(k) Number
- FDA product code
- GWL
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1835
- GUDID distribution status
- In Commercial Distribution
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