Xltek 012001
Xltek 012001 is a Class II device made by Embla Systems, listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830043441), 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 | Number00382830043441 | Date25 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 00382830043441
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Xltek
- Generic name
- Sleep disorder interpretive software
- Model / reference
- 012001
- Primary DI / UDI-DI
- 00382830043441
- FDA product code
- OLV
- GMDN term
- Sleep disorder interpretive software
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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