Block F. EEG REF ID Conversion
Catalogue number 5954859, listed by Draeger Medical Systems, Inc., United States, under Reduced- Montage Standard Electroencephalograph. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K991012 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5954859 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Remi | Epitel | 12 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| Quex S | QX World KFT | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
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.