DeviceClearance

Product code OLW— Neurology

BIS ENGINE

Classification name
Index-Generating Electroencephalograph Software
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
40
First cleared
Most recent

FDA classification definition

“Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.”

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

Market context for product code OLW

FDA has cleared 40 devices under product code OLW between 1996 and 2026, filed by 19 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

last 15 years

Top applicants under product code OLW

Recent clearances under product code OLW

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