FDA Product Code OLW: Index-generating Electroencephalograph Software
Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
Leading manufacturers include Masimo Corporation and Covidien, LLC.
38
Total
38
Cleared
153d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Index-generating Electroencephalograph Software Devices (Product Code OLW)
38 devices
Cleared
Feb 26, 2024
BIS™ Advance Monitoring System
Covidien, LLC
Anesthesiology
350d
Cleared
Feb 25, 2022
Masimo SedLine Sedation Monitor and Accessories
Masimo Corporation
Anesthesiology
498d
About Product Code OLW - Regulatory Context
510(k) Submission Activity
38 total 510(k) submissions under product code OLW since 1996, with 38 receiving FDA clearance (average review time: 153 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
OLW devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →