Burst Suppression Detection Software for Electroencephalograph
3 catalogue numbers from 2069156-001, listed by GE Healthcare Finland OY, Finland, under Burst Suppression Detection Software For Electroencephalograph. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), 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 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | ORT |
| Device type | Burst Suppression Detection Software For Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K132533 |
| Record published | 2016-06-30 |
| Record revised | 2021-10-25 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Storage environment temperature -20 to 60 °C; Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2069156-001 | In distribution | |
| 2040427-001 | In distribution | |
| E-ENTROPY-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Carescape Canvas Smart Display | GE Healthcare Finland OY | 1 |
| Orthonol | RMO | 1 |
| CNS Envision | Natus Neurology Incorporated | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
Recalls Naming This Product
5 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 | Closed |
|---|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2018-09-04 | Class II | Software design | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the | 59,000 units | |
| GE Healthcare Finland OY | 510(k) number | 2018-09-04 | Class II | Software design | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the | 47,937 units | |
| GE Medical Systems, LLC | 510(k) number | 2015-05-04 | Class II | Software design | The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an | 110 (83 units US, 27 units OUS) | 2015-09-15 |
| GE Medical Systems, LLC | 510(k) number | 2014-06-13 | Class II | Software design | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor | 41,992 (20,509 US; 21,483 OUS) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2014-02-28 | Class II | Software design | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. | 676 units OUS | 2015-04-29 |
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.