encevis 1.6
by AIT Austrian Institute of Technology GmbH
encevis 1.6 is a Class II device made by AIT Austrian Institute of Technology GmbH, cleared under FDA 510(k) K171720 on 19 Apr 2018 and listed in FDA GUDID since 11 Jan 2021 (UDI-DI 09120109830078), active 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 | Number09120109830078 | Date11 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171720 | Date19 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 09120109830078
- FDA 510(k) database K171720
Across registries
- FDA 510(k) K171720 decided 19 Apr 2018 Active
- FDA GUDID UDI-DI 09120109830078 listed 11 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K171720
- Listed FDA GUDID 09120109830078
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- encevis
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- 1.6
- Primary DI / UDI-DI
- 09120109830078
- 510(k) Number
- FDA product code
- OMB, OLT, OMA
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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