Device type
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Product code OLZ · Class II · 21 CFR 882.1400 · Neurology
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
Recent 510(k)s
Oct 9, 2026
K261521
Sleep Analysis Module
Neurotronics, LLC
- OLZ
- Class II
Recent recalls
No recalls in the archive for OLZ.