OLT

Non-Normalizing Quantitative Electroencephalograph Software

Product code: OLT
Device name: Non-Normalizing Quantitative Electroencephalograph Software
Device class: Class 2
21 CFR: 21 CFR 882.1400
Medical specialty: Neurology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 56

FDA classification definition

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-19.

Number	Decision date	Applicant	Device name
K254213	2026-08-19	Pascall Systems, Inc.	Pascall Sensor Unit (PSU1) summary
K253767	2026-06-30	Universal Brain	UB ERP System summary
K251881	2025-12-03	Hippoclinic	HippoMind (v1.0) summary
K251366	2025-10-09	Nihon Kohden Corporation	EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG A summary
K240593	2024-08-23	NeuroServo, Inc.	VEEGix EEG System summary

Official FDA classification page: OLT

Classification and pathway per current FDA publications. Data from openFDA (CC0).