Cleared Traditional

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

K242446 · Persyst Development Corporation · Neurology

Jan 2025

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K242446 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)), 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 review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K242446 FDA.gov
FDA Decision	Cleared 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

Device Classification

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