Full-Montage Standard Electroencephalograph
SpO2 connection cord (for Nihon Kohden SpO2 probe)
3manufacturers in China registered for this device type
20catalogue 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 | Nihon Kohden Corp., Japan |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-05 |
| Record revised | 2024-04-15 (version 7) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DH-110A | In distribution | ||
| JL-570T | In distribution | ||
| DH-120A | In distribution | ||
| AAA-17054 | In distribution | ||
| MU-110A | In distribution | ||
| JW-120A | In distribution | ||
| QP-931BK | In distribution | ||
| JW-121A | In distribution | ||
| SB-121A | In distribution | ||
| JE-226AK | In distribution | ||
| QI-123A | In distribution | ||
| BC-112B | In distribution | ||
| JW-126A | In distribution | ||
| JE-125AK | In distribution | ||
| JE-120A-22 | In distribution | ||
| YG-211T | Adult | 30 | In distribution |
| JL-900P | In distribution | ||
| JB-110A | In distribution | ||
| JW-123A | In distribution | ||
| JE-120A-23 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natus | Xltek | 54 |
| Trackit | Lifelines Ltd. | 24 |
| 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 |
|---|---|
| K171124 | 2017-08-25 |
| K120888 | 2012-11-09 |
| K110376 | 2011-07-29 |
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.