OLZ · Class II · 21 CFR 882.1400

FDA Product Code OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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

Leading manufacturers include Beacon Biosignals, Inc., Nox Medical Ehf and Brain Electrophysiology Laboratory Company, LLC.

36
Total
36
Cleared
176d
Avg days
1986
Since
36 devices
25–36 of 36
No devices found for this product code.