Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OLW — Index-Generating Electroencephalograph Software # OLW · Index-Generating Electroencephalograph Software _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW ## Overview - **Product Code:** OLW - **Device Name:** Index-Generating Electroencephalograph Software - **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## 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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K230693.md) | BIS™ Advance Monitoring System | Covidien, LLC | Feb 26, 2024 | SESE | | [K213273](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K213273.md) | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | Sep 1, 2023 | SESE | | [K203113](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K203113.md) | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | Feb 25, 2022 | SESE | | [K202621](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K202621.md) | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | Aug 5, 2021 | SESE | | [K172890](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K172890.md) | SedLine Sedation Monitor | Masimo Corporation | Jan 26, 2018 | SESE | | [K150298](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K150298.md) | Entropy Module, E-ENTROPY-01 | Ge Healthcare Filand OY | Nov 12, 2015 | SESE | | [K083063](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K083063.md) | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | Dec 16, 2008 | SESE | | [K061907](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K061907.md) | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | Mar 27, 2008 | SESE | | [K072286](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K072286.md) | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | Nov 20, 2007 | SESE | | [K071899](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K071899.md) | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | Oct 22, 2007 | SESE | | [K062613](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K062613.md) | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | Jun 18, 2007 | SESE | | [K060900](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K060900.md) | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | Spacelabs Medical, Inc. | Jun 23, 2006 | SESE | | [K060997](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K060997.md) | SNAP II EEG MONITOR | Everest Biomedical Instruments Co. | Jun 15, 2006 | SESE | | [K052981](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K052981.md) | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | Nov 1, 2005 | SESE | | [K052362](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K052362.md) | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | Sep 9, 2005 | SESE | | [K051874](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K051874.md) | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | Physiometrix, Inc. | Sep 2, 2005 | SESE | | [K052145](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K052145.md) | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | GE Healthcare | Aug 23, 2005 | SESE | | [K050835](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K050835.md) | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | May 6, 2005 | SESE | | [K042315](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K042315.md) | CEREBRAL STATE MONITOR - CSM | Danmeter A/S | Jan 21, 2005 | SESE | | [K033543](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K033543.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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