Xltek 4283000
Xltek 4283000 is a Class II device made by Embla Systems, listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830043533), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00382830043533 | Date25 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 00382830043533
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Xltek
- Generic name
- Sleep disorder interpretive software
- Model / reference
- 4283000
- Primary DI / UDI-DI
- 00382830043533
- FDA product code
- GWQ
- GMDN term
- Sleep disorder interpretive software
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWQ (Full-Montage Standard Electroencephalograph).
- Electroencephalograph Recording System by Medelec Intl. Corp.
- DG NERVUS by Medelec, Ltd.
- EEG-5400 Series by NIHON KOHDEN AMERICA, INC.
- NEUROSEARCH-24 OR NRS-24 by Lexicor Medical Technology, Inc.
- Neuroamp EEG Amplifier by Neurocorp, Ltd.
- ISOLATED EEG AMPLIFIER MODULE by Mennen Greatbatch Electonics
- GEODESIC PHOTOGRAMMETRY SYSTEM by Electrical Geodesics, Incorporated
- EEG Leads, 0.6m, reusable, 9 pcs 5947804 by Draeger Medical Systems, Inc.
- NICOLET VOYAGEUR by Nicolet Instrument Corp.
- HORIZON 2000 EEG MONITORING OPTION by Mennen Medical, Inc.