OLW — Index-Generating Electroencephalograph Software Class II
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 |
|---|---|---|---|
| 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 |
| K033543 | mt monitortechnik gmbh and co. kg | NARCOTREND, MODEL COMPACT 4.0 | September 17, 2004 |