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.
FDA 510(k) Cleared Automatic Event Detection Software For Polysomnograph With Electroencephalograph Devices (Product Code OLZ)
About Product Code OLZ - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code OLZ since 1986, with 36 receiving FDA clearance (average review time: 176 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OLZ submissions have been consistent, averaging 160 days recently vs 179 days historically.
OLZ devices are reviewed by the Neurology panel. Browse all Neurology devices →