Trackit 3 BT 12/0
Trackit 3 BT 12/0 (1189) is a Class II device made by Lifelines Limited, cleared under FDA 510(k) K010460 on 14 May 2001 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05060275450189), 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 | Number05060275450189 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK010460 | Date14 May 2001 | StatusActive |
Official records
- AccessGUDID record 05060275450189
- FDA 510(k) database K010460
Across registries
- FDA 510(k) K010460 decided 14 May 2001 Active
- FDA GUDID UDI-DI 05060275450189 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K010460
- Listed FDA GUDID 05060275450189
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trackit
- Generic name
- Electroencephalographic ambulatory recorder
- Model / Ref / Catalog
- Trackit 3 BT 12/0, 1189
- Primary DI / UDI-DI
- 05060275450189
- 510(k) Number
- FDA product code
- GWQ
- GMDN term
- Electroencephalographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- Not in Commercial Distribution
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