OLW — Index-Generating Electroencephalograph Software Class II
FDA product code OLW covers "Index-Generating Electroencephalograph Software", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLW
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260880 | masimo corporation | SedLine Sedation Monitor | July 10, 2026 |
| K230693 | covidien | BIS Advance Monitoring System | February 26, 2024 |
| K213273 | cortical dynamics | Brain Anesthesia Response Monitor (Bar Monitor) | September 1, 2023 |
| K203113 | masimo corporation | Masimo SedLine Sedation Monitor and Accessories | February 25, 2022 |
| K202621 | neurowave systems | NeuroSENSE Monitoring System, Model NS-901 | August 5, 2021 |
| K172890 | masimo corporation | SedLine Sedation Monitor | January 26, 2018 |
| K150298 | ge healthcare filand | Entropy Module, E-ENTROPY-01 | November 12, 2015 |
| K083063 | mennen medical | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | December 16, 2008 |
| K061907 | ge healthcare | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | March 27, 2008 |
| K072286 | aspect medical systems | BIS EEG VISTA MONITOR SYSTEM AND BISX | November 20, 2007 |
| K071899 | mennen medical | BIS MODULE FOR ENVOY PATIENT MONITOR | October 22, 2007 |
| K062613 | aspect medical systems | BIS EEG MONITOR VIEW | June 18, 2007 |
| K060900 | spacelabs medical | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES | June 23, 2006 |
| K060997 | everest biomedical instruments | SNAP II EEG MONITOR | June 15, 2006 |
| K052981 | aspect medical systems | BIS EEG MONITOR, MODEL BISX4 | November 1, 2005 |
| K052362 | aspect medical systems | BIS EEG MONITOR, MODEL A-3000 | September 9, 2005 |
| K051874 | physiometrix | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | September 2, 2005 |
| K052145 | ge healthcare | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | August 23, 2005 |
| K050835 | ge healthcare | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | May 6, 2005 |
| K042315 | danmeter | CEREBRAL STATE MONITOR - CSM | January 21, 2005 |