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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)
5
Summaries archived here
5 (direct download)
510(k) clearances (all years, FDA)
56 (all years; only the last 3 years are listed here)

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.

NumberDecision dateApplicantDevice nameSummary
K2542132026-08-19Pascall Systems, Inc.Pascall Sensor Unit (PSU1)PDF
K2537672026-06-30Universal BrainUB ERP SystemPDF
K2518812025-12-03HippoclinicHippoMind (v1.0)PDF
K2513662025-10-09Nihon Kohden CorporationEEG-1260A Neurofax System (EEG-1260A); JE-940A EEG A…PDF
K2405932024-08-23NeuroServo, Inc.VEEGix EEG SystemPDF

5 summaries are archived here for direct download.

Official FDA classification page: OLT
Classification and pathway per current FDA publications. Data from openFDA (CC0).