Grass CMXL-E-SPC
by Xltek
Grass CMXL-E-SPC is a Class II device made by Xltek, cleared under FDA 510(k) K172711 on 3 Nov 2017 and listed in FDA GUDID since 13 Jul 2018 (UDI-DI 00382830022323), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00382830022323 | Date13 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172711 | Date3 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 00382830022323
- FDA 510(k) database K172711
Across registries
- FDA 510(k) K172711 decided 3 Nov 2017 Active
- FDA GUDID UDI-DI 00382830022323 listed 13 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K172711
- Listed FDA GUDID 00382830022323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Grass
- Generic name
- Electroencephalograph
- Model / Ref / Catalog
- CMXL-E-SPC
- Primary DI / UDI-DI
- 00382830022323
- FDA product code
- GWQ
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- Not in Commercial Distribution
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