R-40 EEG Amplifier + BT
R-40 EEG Amplifier + BT (1377) is a Class II device made by Lifelines Limited, cleared under FDA 510(k) K151600 on 23 Oct 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05060275450394), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 | Number05060275450394 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151600 | Date23 Oct 2015 | StatusActive |
Official records
- AccessGUDID record 05060275450394
- FDA 510(k) database K151600
Across registries
- FDA 510(k) K151600 decided 23 Oct 2015 Active
- FDA GUDID UDI-DI 05060275450394 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K151600
- Listed FDA GUDID 05060275450394
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- R-40
- Generic name
- Electroencephalograph
- Model / Ref / Catalog
- EEG Amplifier + BT, 1377
- Primary DI / UDI-DI
- 05060275450394
- 510(k) Number
- FDA product code
- GWL
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1835
- GUDID distribution status
- Not in Commercial Distribution
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