# GE Medical Systems Information Technologies, Inc. (specification developer, Waukesha, WI): 26 new FDA device listings, incl. analyzer, gas, carbon-dioxide, gaseous-phase

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | GE Medical Systems Information Technologies, Inc. |
| Owner / operator | GE HealthCare Technologies Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Waukesha, WI, US |
| New listings | 26 |
| Devices | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Detector And Alarm, Arrhythmia; Oximeter, Ear; Monitor, St Segment With Alarm; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Product codes | CCK, CBR, DSI, DPZ, MLD, GWQ, OLT, CBS, CBQ, MHX, DSJ, NHO, DQA, OMC, ORT |
| Device classes | Class II |
| Medical specialties | Anesthesiology, Cardiovascular, Neurology, General Hospital |
| Brand names | Monitor B125P; Monitor B105M; B125M Patient Monitor; B125P Patient Monitor; B105P Patient Monitor; B105M Patient Monitor; B155M Patient Monitor; VSP 4 Upgrade Software |
| First new listing | 2026-08-06 |
| Latest new listing | 2026-08-06 |
| FDA registration number | 3001570235 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.