B1X5 Software Upgrade
B125/B105 V1.5 SW Pack (USB) - MD
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 | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| 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 |
| Record published | 2020-11-18 |
| Record revised | 2025-04-17 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1.5 | Withdrawn |
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 |
| BIS Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| BIS module (w accessory kit) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 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.