OLU

Normalizing Quantitative Electroencephalograph Software

Product code

OLU

Device name

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)

13

FDA classification definition

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database 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 (2)

Last three years. Most recent: 2026-06-12.