Component Neuromonitoring System
International (non-U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 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 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| 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 | Moberg Research, Inc., United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K080217 |
| Record published | 2017-12-21 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CNS-EEG-320 | In distribution | |
| CNS-VID-320 | In distribution | |
| CNS-EEG-300 | In distribution | |
| CNS-EEG-210 | In distribution | |
| CNS-VID-300 | In distribution | |
| CNS-PTZ-310 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
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 |
|---|---|---|---|---|---|---|
| Moberg Research, Inc. | 510(k) number | 2023-02-20 | Class II | Under Investigation by firm | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC | 89 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.