FDA Product Code OLT: Non-normalizing Quantitative Electroencephalograph Software
Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
Leading manufacturers include Neuroservo, Inc., Nihon Kohden Corporation and Hippoclinic.
FDA 510(k) Cleared Non-normalizing Quantitative Electroencephalograph Software Devices (Product Code OLT)
About Product Code OLT - Regulatory Context
510(k) Submission Activity
54 total 510(k) submissions under product code OLT since 1981, with 54 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OLT submissions have been consistent, averaging 168 days recently vs 174 days historically.
OLT devices are reviewed by the Neurology panel. Browse all Neurology devices →