Galileo NT Line Software
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | EB Neuro SPA |
|---|---|
| FDA product code | JXE |
| Device type | Device, Nerve Conduction Velocity Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1550 |
| 510(k) | K142064 |
| Record published | 2020-05-25 |
| Record revised | 2025-05-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B8640053000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultra-Drive® Tool | Biomet Orthopedics | 40 |
| Advance | Neurometrix, Inc. | 18 |
| DPNCheck | Impulse Technology LLC | 7 |
| Chalgren | Chalgren Enterprises, Inc. | 5 |
| Rhythmlink® | Rhythmlink International, LLC | 4 |
| Ultra-Drive | Biomet Orthopedics | 3 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| NC-stat DPNCheck | Neurometrix, Inc. | 2 |
| NeMus 1 | EB Neuro SPA | 2 |
| Sierra Wave | Cadwell Industries, Inc. | 2 |
| Cascade | Cadwell Industries, Inc. | 2 |
| NeMus PC Peripheral | EB Neuro SPA | 1 |
Showing 12 of 32. All products under Device, Nerve Conduction Velocity Measurement
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.