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 Advanced Brain Monitoring, Inc., Embla Systems and Beacon Biosignals, Inc..

37
Total
37
Cleared
178d
Avg days
1986
Since