Natus
"Trex Cable for External Integrated Style Battery Pack"
3manufacturers in China registered for this device type
54catalogue numbers in this listing
2510(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 | Xltek, Canada |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| 510(k) | K053386 |
| Record published | 2016-09-13 |
| Record revised | 2025-10-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 006550 | In distribution | |
| PK1174 | In distribution | |
| PK1055HDM | In distribution | |
| 024229 | In distribution | |
| PK1258 | In distribution | |
| 006562 | In distribution | |
| 102505 | In distribution | |
| 016868 | In distribution | |
| 016862 | In distribution | |
| 016280 | In distribution | |
| 014161 | In distribution | |
| 022664 | In distribution | |
| 019245 | In distribution | |
| 014162 | In distribution | |
| 102710 | In distribution | |
| 022134 | In distribution | |
| 002933 | In distribution | |
| 019727 | In distribution | |
| 014160 | In distribution | |
| 013926 | In distribution | |
| PK1072-NTB-9 | In distribution | |
| 102507 | In distribution | |
| 10406 | In distribution | |
| 10343 | In distribution | |
| 014165 | In distribution | |
| 102506 | In distribution | |
| 016281 | In distribution | |
| 016867 | In distribution | |
| 10392 | In distribution | |
| 002932 | In distribution | |
| 016282 | In distribution | |
| 013891 | In distribution | |
| 008043 | In distribution | |
| 016271 | In distribution | |
| W6233H | In distribution | |
| 016269 | In distribution | |
| W6348H | In distribution | |
| 10399 | In distribution | |
| 021911 | In distribution | |
| PK1173 | In distribution | |
| 028066 | In distribution | |
| 014163 | In distribution | |
| 016278 | In distribution | |
| 10405 | In distribution | |
| 002876 | In distribution | |
| 021743-9 | In distribution | |
| 10384 | In distribution | |
| 016279 | In distribution | |
| 002874 | In distribution | |
| 016270 | In distribution | |
| W6232H | In distribution | |
| 014164 | In distribution | |
| 102504XL | In distribution | |
| 013931 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K014146 | 2002-01-14 |
| K014147 | 2002-01-14 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) | 510(k) number | 2015-11-11 | Class II | Software Manufacturing/Software Deployment | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. | 56 (43 US, 13 OUS) | 2016-10-03 |
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.