Component Neuromonitoring System
International (non-U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.
3manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Moberg Research, Inc., United States |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| 510(k) | K080217 |
| Record published | 2017-12-21 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CNS-VID-310 | In distribution | |
| CNS-350 | In distribution | |
| CNS-320 | In distribution | |
| CNS-300 | In distribution | |
| CNS-EEG-310 | In distribution | |
| CNS-PTZ-300 | In distribution | |
| CNS-INX-310 | In distribution | |
| CNS-EEG-200 | In distribution | |
| CNS-EEG-220 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natus | Xltek | 54 |
| Trackit | Lifelines Ltd. | 24 |
| Full-Montage Standard Electroencephalograph | Nihon Kohden Corp. | 20 |
| Enobio Dx | Neuroelectrics Barcelona SL | 19 |
| Compumedics Neuvo | Compumedics Limited | 19 |
| Natus | Natus Neurology Incorporated | 18 |
| X-Series | Advanced Brain Monitoring, Inc. | 16 |
| Full-Montage Standard Electroencephalograph | Nihon Kohden America, Inc. | 15 |
| Grass | Xltek | 13 |
| Seer Home | Seer Medical Pty, Ltd. | 10 |
| Compumedics SynAmps RT | Compumedics Limited | 9 |
| X-Series, X8 | Advanced Brain Monitoring, Inc. | 7 |
Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Moberg Research, Inc. | 510(k) number | 2023-02-20 | Class II | Under Investigation by firm | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC | 89 units |
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.