OLW

Index-Generating Electroencephalograph Software

Product code: OLW
Device name: Index-Generating Electroencephalograph Software
Device class: Class 2
21 CFR: 21 CFR 882.1400
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 40

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.

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

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

Last three years. Most recent: 2026-08-13.

Number	Decision date	Applicant	Device name	Summary
K260907	2026-08-13	Covidien LP	BIS Advance pEEG Module	PDF
K260880	2026-07-10	Masimo Corporation	SedLine Sedation Monitor	PDF
K230693	2024-02-26	Covidien, LLC	BIS Advance Monitoring System	PDF

3 summaries are archived here for direct download.

Official FDA classification page: OLW

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