FDA Product Code OLU: Normalizing Quantitative Electroencephalograph Software
Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.
Leading manufacturers include Medeia, Inc., iMediSync, Inc. and Neurofield, Inc..
FDA 510(k) Cleared Normalizing Quantitative Electroencephalograph Software Devices (Product Code OLU)
About Product Code OLU - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code OLU since 1991, with 12 receiving FDA clearance (average review time: 300 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under OLU have taken an average of 220 days to reach a decision - down from 307 days historically, suggesting improved FDA processing for this classification.
OLU devices are reviewed by the Neurology panel. Browse all Neurology devices →