OmniPro System
The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center
3manufacturers in China registered for this device type
4catalogue 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 | Mays & Asscoiates |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| 510(k) | K050143 |
| Record published | 2019-12-09 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | serial number |
| Sizes | Weight 390 to 675 g; height 3.8 to 4.5 cm; width 15.5 to 15.6 cm; length 15.9 to 20.5 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OmniPro EEG System | In distribution | |
| OmniAmp EEG Module | Weight 675 g | In distribution |
| OmniAmp PSG System | In distribution | |
| OmniPro Interface Module | Weight 390 g | 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 |
| Component Neuromonitoring System | Moberg Research, Inc. | 9 |
Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph
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.