Carescape
Carescape 19 Inch Display D19KT
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K131414 |
| Record published | 2016-06-03 |
| Record revised | 2025-05-09 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 90 % RH; Handling environment temperature 0 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19 inch Display D19KT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 117 |
| Natus Medical | Natus Medical Incorporated | 25 |
| QScreen Set | Path | 24 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
Recalls Naming This Product
3 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 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.