X-Series
External Syncing Unit - Multi-Channel Kit (PAN 1026A)
3manufacturers in China registered for this device type
16catalogue 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 | Advanced Brain Monitoring, Inc., United States |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K131383 |
| Record published | 2025-01-29 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 15 to 93 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature -25 to 70 °C; Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XS30-1015.LE | In distribution | |
| UN03-5205 | In distribution | |
| XS30-1007.LE | In distribution | |
| XS30-1006.LE | In distribution | |
| XS30-1001 | In distribution | |
| XS30-1007 | In distribution | |
| XS10-4321 | In distribution | |
| XS24-4321 | In distribution | |
| XS30-1002, XS30-1003 | In distribution | |
| XS30-1001.LE | In distribution | |
| XS30-1001.LE | In distribution | |
| XS30-1004, XS30-1005 | In distribution | |
| ES31-1001, ES31-1003 | In distribution | |
| UN03-5206 | In distribution | |
| XS30-1007.LE | In distribution | |
| XS30-1007.LE | 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 |
| 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 |
|---|---|
| K131383 | 2013-11-27 |
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.