Xltek 2013031
Xltek 2013031 is a multiple physiological signal amplifier (FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Embla Systems, listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830023771), 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 | Number00382830023771 | Date25 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 00382830023771
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Xltek
- Generic name
- Multiple physiological signal amplifier
- Model / reference
- 2013031
- Primary DI / UDI-DI
- 00382830023771
- FDA product code
- MNR
- GMDN term
- Multiple physiological signal amplifier
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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