Geodesic EEG System
Electroencephalograph
3manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
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 | Electrical Geodesics, Inc., United States |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Record published | 2016-10-03 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 10 to 35 °C; Handling environment humidity 5 to 95 % RH |
| Sizes | Width 150 cm; length 102 cm |
| Distribution end date | 2021-07-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GES 400 Series | Width 150 cm | Withdrawn |
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 |
| Component Neuromonitoring System | Moberg Research, Inc. | 9 |
Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112353 | 2012-02-17 |
| K043309 | 2005-01-26 |
| K033399 | 2004-08-04 |
| K012079 | 2001-09-19 |
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.