FDA Registration
Active
🇺🇸 United States
Portrait VSM
Reg #: 3012359877
·
FEI: 3012359877
·
Expires 2025
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- GE Medical Systems Information Technologies, Inc.
- Registration Number
- 3012359877
- FEI Number
- 3012359877
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9900 Innovation Drive
- City
- Wauwatosa
- State
- WI
- ZIP
- 53226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233810
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-04-26 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2024-04-26 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-04-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-04-26 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2024-04-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-04-26 |
Proprietary Names
Portrait VSM
Portrait VSM Vital Signs Monitor
Portrait VSM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility