FDA device listing
CARESCAPE DOCK FO,CARESCAPE ECG,CARESCAPE ONE,CARESCAPE PRES,CARESCAPE SPO2,CARESCAPE TEMP
FDA device listing 1481395238 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | CARESCAPE DOCK FO,CARESCAPE ECG,CARESCAPE ONE,CARESCAPE PRES,CARESCAPE SPO2,CARESCAPE TEMP |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K213234 |
| Product codes | BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL and 4 more |
| Device names | BZQ - Monitor, Breathing Frequency, CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DPS - Electrocardiograph, DPZ - Oximeter, Ear, DQA - Oximeter, DQK - Computer, Diagnostic, Programmable, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSI - Detector And Alarm, Arrhythmia, DSJ - Alarm, Blood-Pressure, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer and 4 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.2375, 870.1025, 870.1100, 870.1110, 870.1130, 870.1425, 870.2300, 870.2340, 870.2700, 870.2710, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | GE HEALTHCARE FINLAND OY, 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., Repair Operations Center |
| Establishment registrations | 1651104, 9610105, 3001570235, 3008729547, 3012359877, 3013679558 |
| FEI numbers | 3001570235, 3002737156, 3002806783, 3008729547, 3012359877, 3013679558 |
| Establishment operations | Manufacturer, Remanufacturer, 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