K240993
- 510(k) number
- K240993
- Device name
- encevis (2.1)
- Applicant
- Ait Austrian Institute of Technology GmbH AT
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2024-09-27
- Date received
- 2024-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K240993.pdf
Official FDA record: K240993
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.