Datrix VX3+ Series L
by Datrix LLC
Datrix VX3+ Series L is a Class II device made by Datrix LLC, cleared under FDA 510(k) K031074 on 15 Oct 2003 and listed in FDA GUDID since 26 Aug 2017 (UDI-DI 00851074007316), active 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 | Number00851074007316 | Date26 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031074 | Date15 Oct 2003 | StatusActive |
Official records
- AccessGUDID record 00851074007316
- FDA 510(k) database K031074
Across registries
- FDA 510(k) K031074 decided 15 Oct 2003 Active
- FDA GUDID UDI-DI 00851074007316 listed 26 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K031074
- Listed FDA GUDID 00851074007316
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Datrix
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- VX3+ Series L
- Primary DI / UDI-DI
- 00851074007316
- 510(k) Number
- FDA product code
- MWJ
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
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