FDA device listing
CARESCAPE Central Station,CARESCAPE Central Station v2,CARESCAPE Central Station v3,CSCS,CSCS v2,CSCS v3
FDA device listing 1610211832 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | CARESCAPE Central Station,CARESCAPE Central Station v2,CARESCAPE Central Station v3,CSCS,CSCS v2,CSCS v3 |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K162012 |
| Product codes | DQK, DSI, DXJ |
| Device names | DQK - Computer, Diagnostic, Programmable, DSI - Detector And Alarm, Arrhythmia, DXJ - Display, Cathode-Ray Tube, Medical |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1425, 870.2450 |
| Review panels | Cardiovascular |
| Registered establishments | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V., GE Medical Systems Information Technologies, Inc., WIPRO GE HEALTHCARE PRIVATE Ltd. |
| Establishment registrations | 1651104, 3001570235, 3007734888, 3008729547, 3012359877 |
| FEI numbers | 3001570235, 3002737156, 3007734888, 3008729547, 3012359877 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database