OLW · Index-Generating Electroencephalograph Software
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLW |
|---|---|
| Device Name | Index-Generating Electroencephalograph Software |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230693 | BIS Advance Monitoring System | Covidien, LLC | Feb 26, 2024 | SESE |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | Sep 1, 2023 | SESE |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | Feb 25, 2022 | SESE |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | Aug 5, 2021 | SESE |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | Jan 26, 2018 | SESE |
| K150298 | Entropy Module, E-ENTROPY-01 | Ge Healthcare Filand OY | Nov 12, 2015 | SESE |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | Dec 16, 2008 | SESE |
| K061907 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | Mar 27, 2008 | SESE |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | Nov 20, 2007 | SESE |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | Oct 22, 2007 | SESE |
| K062613 | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | Jun 18, 2007 | SESE |
| K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | Spacelabs Medical, Inc. | Jun 23, 2006 | SESE |
| K060997 | SNAP II EEG MONITOR | Everest Biomedical Instruments Co. | Jun 15, 2006 | SESE |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | Nov 1, 2005 | SESE |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | Sep 9, 2005 | SESE |
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | Physiometrix, Inc. | Sep 2, 2005 | SESE |
| K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | GE Healthcare | Aug 23, 2005 | SESE |
| K050835 | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | May 6, 2005 | SESE |
| K042315 | CEREBRAL STATE MONITOR - CSM | Danmeter A/S | Jan 21, 2005 | SESE |
| K033543 | NARCOTREND, MODEL COMPACT 4.0 | Mt Monitortechnik GmbH & Co. KG | Sep 17, 2004 | SESE |
Top Applicants
- Aspect Medical Systems, Inc. — 12 clearances
- Physiometrix, Inc. — 4 clearances
- GE Healthcare — 3 clearances
- Datex-Ohmeda — 2 clearances
- Masimo Corporation — 2 clearances
