510(k) K211452
K211452 is an FDA 510(k) premarket notification submitted by Austrian Institute of Technology GmbH for the device "Encevis". The FDA issued a decision of Substantially Equivalent on December 2, 2021. The device falls under product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2021
- Date Received
- May 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user