FDA device listing
ApexPro 400 MHz Receiver,ApexPro 600 MHz Receiver,APEXPRO CH NONIN XPOD OXIMETER,ApexPro CH Transmitter,ApexPro FH…
FDA device listing 1478915015 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | ApexPro 400 MHz Receiver,ApexPro 600 MHz Receiver,APEXPRO CH NONIN XPOD OXIMETER,ApexPro CH Transmitter,ApexPro FH Transceiver,APEXPRO QUAD RECEIVER MODULE,APEXPRO RECEIVER SUBSYSTEM,ApexPro Telemetry System,CARESCAPE T14 Transmitter,CARESCAPE T4 Transmitter,CARESCAPE Telemetry Server,CARESCAPE Telemetry Server V4,CARESCAPE TELEMETRY SERVER V4 UPGRADE,CARESCAPE TELEMETRY SYSTEM,CARESCAPE Telemetry… |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K080251 |
| Product codes | MHX |
| Device names | MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025 |
| 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. |
| Establishment registrations | 1651104, 3001570235, 3008729547, 3012359877 |
| FEI numbers | 3001570235, 3002737156, 3008729547, 3012359877 |
| Establishment operations | Manufacturer, 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