Carescape B650
Carescape B650 MBB313 (ATO Model)
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), 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 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | NHP |
| Device type | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191149 |
| Record published | 2020-03-11 |
| Record revised | 2022-08-23 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MBB313 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Medical Systems Information Technologies, Inc. | 2 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 2 |
| Carescape | GE Medical Systems Information Technologies, Inc. | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, 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 | 54800 units |
| 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 | 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.