K242446 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)). 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 January 22, 2025, 159 days after receiving the submission on August 16, 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 | K242446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2024 |
| Decision Date | January 22, 2025 |
| Days to Decision | 159 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 |