Trackit
24 catalogue numbers from Trackit 24/8 Kit, listed by Lifelines Ltd., United Kingdom, under Full-Montage Standard Electroencephalograph. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
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 | Lifelines Ltd., United Kingdom |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K010460 |
| Record published | 2016-09-09 |
| Record revised | 2025-11-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Trackit 24/8 Kit | Withdrawn | |
| Trackit 20/4/B Kit | Withdrawn | |
| Trackit 3 BT 12/0/B | Withdrawn | |
| Trackit 24/8/B Kit | Withdrawn | |
| Trackit 3 BT 20/4/B | Withdrawn | |
| Trackit 32/0/B Kit | Withdrawn | |
| Trackit 3 BT 24/8/B | Withdrawn | |
| Trackit 24/0 Kit | Withdrawn | |
| Trackit 18/8/B Kit | Withdrawn | |
| Trackit 20/4 Kit | Withdrawn | |
| Trackit 24/0/B Kit | Withdrawn | |
| Trackit 32/0 Kit | Withdrawn | |
| Trackit 3 BT 32/0 | Withdrawn | |
| Trackit 12/0 Kit | Withdrawn | |
| Trackit 3 BT 24/0/B | Withdrawn | |
| Trackit 3 BT 24/0 | Withdrawn | |
| Trackit 12/0/B Kit | Withdrawn | |
| Trackit 3 BT 18/8 | Withdrawn | |
| Trackit 3 BT 18/8/B | Withdrawn | |
| Trackit 3 BT 32/0/B | Withdrawn | |
| Trackit 3 BT 20/4 | Withdrawn | |
| Trackit 18/8 Kit | Withdrawn | |
| Trackit 3 BT 24/8 | Withdrawn | |
| Trackit 3 BT 12/0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natus | Xltek | 54 |
| 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 |
| X-Series, X8 | Advanced Brain Monitoring, Inc. | 7 |
Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172271 | 2018-05-04 |
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.