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.
2
Total
2
Cleared
424d
Avg days
2022
Since
List of Index-generating Electroencephalograph Software devices cleared through 510(k)
2 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
How to use this database
This page lists all FDA 510(k) submissions for Index-generating Electroencephalograph Software devices (product code OLW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →