FDA Product Code OMB: Automatic Event Detection Software For Full-montage Electroencephalograph
Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
Leading manufacturers include Ceribell, Inc., Persyst Development Corporation and LVIS Corporation.
FDA 510(k) Cleared Automatic Event Detection Software For Full-montage Electroencephalograph Devices (Product Code OMB)
About Product Code OMB - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code OMB since 1987, with 41 receiving FDA clearance (average review time: 159 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OMB have taken an average of 183 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
OMB devices are reviewed by the Neurology panel. Browse all Neurology devices →