FDA Product Code
FDA Product Code OLU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K222838 | iSyncBrain©-C | iMediSync, Inc. | 2023-03-16 | Traditional | PDF ↗ |
| K212684 | BrainView QEEG Software | Medeia, Inc. | 2023-01-28 | Traditional | PDF ↗ |
| K202588 | BNA Platform | Elminda, Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | 2020-01-24 | Traditional | PDF ↗ |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018-07-01 | Traditional | PDF ↗ |
| K121119 | BNA ANALYSIS SYSTEM | Eiminda , Ltd. | 2014-07-25 | Traditional | PDF ↗ |
| K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | 2012-03-09 | Traditional | PDF ↗ |
| K050192 | BRC SOFTWARE PRODUCT | Brc Operations Pty Limited | 2005-10-20 | Traditional | PDF ↗ |
| K041263 | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | 2004-08-03 | Traditional | PDF ↗ |
| K974748 | NEUROMETRIC ANALYSIS SYSTEM | Nxlink, Ltd. | 1998-07-10 | Traditional | PDF ↗ |
| K904294 | QSI 9500 | Quantified Signal Imaging, Inc. | 1991-07-30 | Traditional | PDF ↗ |
Product code OLU · Class II · Neurology. Data: openFDA.