FDA Registration
Active
🇫🇮 Finland
Airway Gas Option
Reg #: 9610105
·
FEI: 3002806783
·
Expires 2025
Products
17
Proprietary Names
2
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- GE HEALTHCARE FINLAND OY
- Registration Number
- 9610105
- FEI Number
- 3002806783
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KUORTANEENKATU 2
- City
- HELSINKI Uusimaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K133576
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
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2014-03-06 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2014-03-06 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2014-03-06 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2014-03-06 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2014-03-06 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2014-03-06 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2014-03-06 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2014-03-06 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2014-03-06 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2014-03-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2014-03-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-03-06 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2014-03-06 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2014-03-06 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-03-06 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2014-03-06 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2014-03-06 |
Proprietary Names
Airway Gas Option
N-CAiO
Establishment Types
Manufacture Medical Device