K240993 is an FDA 510(k) clearance for the encevis (2.1). This device is classified as a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II - Special Controls, product code OMB).
Submitted by Ait Austrian Institute of Technology GmbH (Vienna, AT). The FDA issued a Cleared decision on September 27, 2024, 169 days after receiving the submission on April 11, 2024.
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 | K240993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 169 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 |