NIRO-200NX
The NIRO-200NX uses near-infrared light to follow regional hemoglobin oxygen saturation and relative oxygenated and deoxygenated hemoglobin levels in the brain or other tissue beneath…
The NIRO-200NX uses near-infrared light to follow regional hemoglobin oxygen saturation and relative oxygenated and deoxygenated hemoglobin levels in the brain or other tissue beneath skin-mounted probes. It is an adjunct trend monitor used alongside other clinical information.
Each probe has a light source and two photodiodes at different distances from it. The equipment analyzes detected light using the absorption properties of oxygenated and deoxygenated hemoglobin, combining the signals to calculate saturation and changes in relative hemoglobin levels.
Interpretation Scope
The equipment is reusable. Its trend information must not serve as the sole basis for diagnosis or therapy, and the clinical value of those trends in disease states has not been established.
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 | Hamamatsu Photonics K.K., Japan |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K143219 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C10448-20 | 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 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| 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 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162117 | 2016-10-25 |
| K143219 | 2015-07-31 |
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.