E-Eegx
E-EEGX is a single-width plug-in interface module for compatible CARESCAPE Bx50 V3 patient monitors. It connects the host monitor to an N-EEGX headbox and patient accessories for monitoring…
E-EEGX is a single-width plug-in interface module for compatible CARESCAPE Bx50 V3 patient monitors. It connects the host monitor to an N-EEGX headbox and patient accessories for monitoring brain electrical activity, frontal muscle activity and auditory evoked potentials.
The headbox measures the patient signals and sends digitized data to E-EEGX for transfer to the monitor. The module also generates the stimuli used for auditory evoked-potential measurement and performs part of that measurement’s data processing.
Listed Item
E-Eegx MJD101, E-Eegx Module Assembly USA
Measurement Channels
The connected N-EEGX headbox acquires four real-time EEG channels, one frontal electromyography channel and two auditory evoked-potential channels. EEG accessories connect the headbox to the patient. The module, headbox and accessories operate together as a hospital monitoring system for qualified medical personnel.
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 | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | OLT |
| Device type | Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191322 |
| Record published | 2022-07-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -25 to 60 °C; Handling environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MJD101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden America, Inc. | 28 |
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden Corp. | 18 |
| Neurofax | Nihon Kohden America, Inc. | 14 |
| Stratus EEG | Kvikna Medical ehf | 4 |
| Nihon Kohden, EEG-1200A Series Neurofax | Nihon Kohden Corp. | 4 |
| Component Neuromonitoring System | Moberg Research, Inc. | 3 |
| Easy III | Cadwell Industries, Inc. | 3 |
| GCX | Nihon Kohden America, Inc. | 3 |
| Neurofax | Nihon Kohden Corp. | 2 |
| Non-Normalizing Quantitative Electroencephalograph Software | GE Healthcare Finland OY | 2 |
| Lifelines iEEG Portable Yoga Tablet No Video | Kvikna Medical ehf | 1 |
| Persyst Mobile App | Persyst Development LLC | 1 |
Showing 12 of 38. All products under Non-Normalizing Quantitative Electroencephalograph Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191322 | 2020-01-22 |
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.