FDA device listing
CARESCAPE B650,CARESCAPE RAD,CARESCAPE SOFTWARE V3.2,E-musb
FDA device listing 1513812715 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | CARESCAPE B650,CARESCAPE RAD,CARESCAPE SOFTWARE V3.2,E-musb |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K213181 |
| Product codes | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA and 23 more |
| Device names | BZK - Spirometer, Monitoring (W/Wo Alarm), BZL - Computer, Oxygen-Uptake, BZQ - Monitor, Breathing Frequency, CAP - Monitor, Airway Pressure (Includes Gauge And/Or Alarm), CBQ - Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), CBR - Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), CBS - Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, CCL - Analyzer, Gas, Oxygen, Gaseous-Phase, DPS - Electrocardiograph, DPZ - Oximeter, Ear, DQA - Oximeter and 23 more |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.1730, 868.1850, 868.2375, 868.2600, 868.2775, 870.1025, 870.1100 and 12 more |
| Review panels | Anesthesiology, Cardiovascular, General Hospital, Neurology |
| 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., Repair Operations Center |
| Establishment registrations | 1651104, 9610105, 3008729547, 3013679558 |
| FEI numbers | 3002737156, 3002806783, 3008729547, 3013679558 |
| Establishment operations | Manufacturer, Remanufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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