Data / Medical devices / Austria / Ait Austrian Institute Of Technology GMBH
Ait Austrian Institute Of Technology GMBH: FDA-registered device maker in Vienna Wien, Austria, 3 510(k) clearances
Ait Austrian Institute Of Technology GMBH is registered with the FDA (registration 3017374042) in Vienna Wien, Austria. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017374042
- Address
- Giefingasse 4, Vienna Wien, Austria, 1210
- Owner or operator
- AIT Austrian Institute of Technology GmbH (10077267)
- Roles
- Manufacturer
- First device listed
- August 19, 2020
- Registered through
- 2026
- Brand names listed
- encevis, encevis 2.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplitude-Integrated Electroencephalograph | OMA | 2 | Manufacturer | accessdata.fda.gov |
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 2 | Manufacturer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2024 | K240993 | encevis (2.1) | OMB | Substantially Equivalent | Ait Austrian Institute of Technology GmbH | accessdata.fda.gov |
| December 2, 2021 | K211452 | Encevis | OMB | Substantially Equivalent | Austrian Institute of Technology GmbH | accessdata.fda.gov |
| April 19, 2018 | K171720 | encevis | OMB | Substantially Equivalent | Ait Austrian Institute of Technology GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Amplitude-Integrated Electroencephalograph
- All makers of Automatic Event Detection Software For Full-Montage Electroencephalograph
Updated September 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.