DeviceClearance

Product code OLU— Neurology

BNA ANALYSIS SYSTEM

Classification name
Normalizing Quantitative Electroencephalograph Software
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
13
First cleared
Most recent

FDA classification definition

“Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.”

— U.S. Food and Drug Administration, device classification record for product code OLU under 21 CFR 882.1400, via openFDA

Market context for product code OLU

FDA has cleared 13 devices under product code OLU between 1991 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OLU

Recent clearances under product code OLU

Data sourced from openFDA. This site is unofficial and independent of the FDA.