Full-Montage Standard Electroencephalograph
SpO2 connection cord (for Nihon Kohden SpO2 probe)
3manufacturers in China registered for this device type
15catalogue numbers in this listing
15510(k) clearances naming this product code
1recall
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 America, 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) | K944678 |
| Record published | 2016-09-19 |
| Record revised | 2021-11-10 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| JE-120A-24 | In distribution | ||
| MU-110A | In distribution | ||
| NE-113A | In distribution | ||
| NE-311A | In distribution | ||
| DH-110A | In distribution | ||
| QI-120A | In distribution | ||
| QI-124A | In distribution | ||
| JE-425A | In distribution | ||
| PE-210AK | In distribution | ||
| JE-120A | In distribution | ||
| JL-900P | In distribution | ||
| YG-211T | Adult | 30 | In distribution |
| JB-110A | In distribution | ||
| JE-125AK | In distribution | ||
| QI-123A | 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 |
| 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 |
|---|---|
| K113117 | 2012-03-22 |
| K944678 | 1995-05-22 |
| K915096 | 1992-03-11 |
| K902550 | 1991-03-19 |
| K884537 | 1988-12-29 |
| K874796 | 1988-01-19 |
| K854663 | 1986-08-20 |
| K842714 | 1984-09-25 |
| K831324 | 1983-05-27 |
| K823140 | 1982-12-07 |
| K820066 | 1982-02-04 |
| K802887 | 1980-12-16 |
| K791233 | 1979-09-12 |
| K791150 | 1979-09-12 |
| K791234 | 1979-09-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2020-12-21 | Class II | Device Design | Medical device non-conformance to electrical safety standard (IEC 60601-1). | 189 Units |
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.