FDA device listing
DATEX-OHMEDA S/5 E-PSM(P) MODULE,LONG PSM POLE MOUNT,PSM MODULE BUS ADAPTER,SHORT PSM POLE MOUNT,TruSignal SpO2 Ear…
FDA device listing 1035789667 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | DATEX-OHMEDA S/5 E-PSM(P) MODULE,LONG PSM POLE MOUNT,PSM MODULE BUS ADAPTER,SHORT PSM POLE MOUNT,TruSignal SpO2 Ear Sensor, GE connector (TS-E4-GE),TruSignal SpO2 Finger Sensor, GE connector (TS-F4-GE) |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K062576 |
| Product codes | DPS, DPZ, DQA, DRQ, DRT, DSK, DXN, FLL, MHX, MLD |
| Device names | DPS - Electrocardiograph, DPZ - Oximeter, Ear, DQA - Oximeter, DRQ - Amplifier And Signal Conditioner, Transducer Signal, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), MLD - Monitor, St Segment With Alarm |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1110, 870.1130, 870.2060, 870.2300, 870.2340, 870.2700, 870.2710, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | GE HEALTHCARE FINLAND OY, GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. |
| Establishment registrations | 9610105, 3008729547 |
| FEI numbers | 3002806783, 3008729547 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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