Carescape B850
Carescape B850 MBC323 (ATO Model)
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), 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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213336 |
| Record published | 2022-05-13 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 15 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MBC323 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 4 |
| Trulink | Spacelabs Healthcare (Washington), Inc | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| SMR integrated mount accessory Kit | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 547 units |
| GE Healthcare Finland OY | UDI-DI | 2024-04-05 | Class II | Software design | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU tim | 25268 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.