K222002 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software. This device is classified as a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II - Special Controls, product code OMB).
Submitted by Persyst Development Corporation (Solana Beach, US). The FDA issued a Cleared decision on December 30, 2022, 176 days after receiving the submission on July 7, 2022.
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 | K222002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2022 |
| Decision Date | December 30, 2022 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| 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 |