BIS Module (W Accessory Kit)
Catalogue number 115-046969-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Index-Generating Electroencephalograph Software. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), 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 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | OLW |
| Device type | Index-Generating Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K190011 |
| Record published | 2020-05-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-046969-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BIS | Covidien LP | 57 |
| RD Sedline | Masimo Corporation | 2 |
| SedLine | Masimo Corporation | 2 |
| EEG Module w/ Cable | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| B1X5 Software Upgrade | GE Medical Systems Information Technologies, Inc. | 1 |
| BIS Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| NeuroSENSE | Neurowave Systems Inc. | 1 |
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.