K211452 is an FDA 510(k) clearance for the Encevis. This device is classified as a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II - Special Controls, product code OMB).
Submitted by Austrian Institute of Technology GmbH (Vienna, AT). The FDA issued a Cleared decision on December 2, 2021, 206 days after receiving the submission on May 10, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. 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.
| 510(k) Number | K211452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2021 |
| Decision Date | December 02, 2021 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OMB - Automatic Event Detection Software For Full-montage Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | 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 |