OLZ

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Product code

OLZ

Device name

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Device class

Class 2

21 CFR

21 CFR 882.1400

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

37

FDA classification definition

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

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

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-06-27.

7 summaries are archived here for direct download.