FDA Registration
Active
🇺🇸 United States
E-musb
Reg #: 1651104
·
FEI: 3002737156
·
Expires 2025
Products
35
Proprietary Names
3
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Registration Number
- 1651104
- FEI Number
- 3002737156
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 465 PAN AMERICAN DR STE 11
- City
- EL PASO
- State
- TX
- ZIP
- 79907
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213181
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-04-20 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-04-20 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2022-04-20 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-04-20 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2022-04-20 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-04-20 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2022-04-20 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-04-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-04-20 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2022-04-20 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-04-20 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2022-04-20 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2022-04-20 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2022-04-20 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-04-20 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2022-04-20 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2022-04-20 |
| Cerebral Oximeter | QEM | Class 2 | Cardiovascular | No | 2022-04-20 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-04-20 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2022-04-20 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2022-04-20 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2022-04-20 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2022-04-20 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2022-04-20 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2022-04-20 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-04-20 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-04-20 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2022-04-20 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-04-20 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-04-20 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-04-20 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-04-20 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2022-04-20 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2022-04-20 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-04-20 |
Proprietary Names
E-musb
CARESCAPE B650
CARESCAPE RAD
Establishment Types
Repack or Relabel Medical Device