OLU · Normalizing Quantitative Electroencephalograph Software
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLU |
|---|---|
| Device Name | Normalizing Quantitative Electroencephalograph Software |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | Sep 20, 2024 | SESE |
| K222838 | iSyncBrain©-C | iMediSync, Inc. | Mar 16, 2023 | SESE |
| K212684 | BrainView QEEG Software | Medeia, Inc. | Jan 28, 2023 | SESE |
| K202588 | BNA Platform | Elminda, Ltd. | Dec 7, 2020 | SESE |
| K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | Jan 24, 2020 | SESE |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | Jul 1, 2018 | SESE |
| K121119 | BNA ANALYSIS SYSTEM | Eiminda , Ltd. | Jul 25, 2014 | SESE |
| K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | Mar 9, 2012 | SESE |
| K050192 | BRC SOFTWARE PRODUCT | Brc Operations Pty Limited | Oct 20, 2005 | SESE |
| K041263 | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | Aug 3, 2004 | SESE |
| K974748 | NEUROMETRIC ANALYSIS SYSTEM | Nxlink, Ltd. | Jul 10, 1998 | SESE |
| K904294 | QSI 9500 | Quantified Signal Imaging, Inc. | Jul 30, 1991 | SESE |
Top Applicants
- Applied Neuroscience, Inc. — 1 clearance
- Brainmaster Technologies, Inc. — 1 clearance
- Brc Operations Pty Limited — 1 clearance
- Corscience GmbH & Co. KG — 1 clearance
- Eiminda , Ltd. — 1 clearance
