Neurovirtual
Polysomnograph and Electroencephalograph BWIII PSG Plus
3manufacturers in China registered for this device type
5catalogue numbers in this listing
3510(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 | Neurovirtual USA, Inc., United States |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K112107 |
| Record published | 2019-11-26 |
| Record revised | 2023-06-20 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -40 to 65 °C; Handling environment temperature 0 to 40 °C; Storage environment atmospheric pressure 70 to 102 KiloPascal; Handling environment atmospheric pressure 70 to 102 KiloPascal; Storage environment humidity 20 to 80 % RH; Handling environment humidity 20 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BWIII EEG Plus | In distribution | |
| BWIII Basics | In distribution | |
| BWMini EEG | In distribution | |
| BWIII EEG | In distribution | |
| BWIII PSG Plus | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191492 | 2020-04-24 |
| K131335 | 2015-02-03 |
| K112107 | 2011-10-28 |
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.