FDA Registration
Active
🇨🇦 Canada
ISA CO2
Reg #: 8022257
·
FEI: 3003757840
·
Expires 2025
Products
21
Proprietary Names
1
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- CHANGE HEALTHCARE CANADA COMPANY
- Registration Number
- 8022257
- FEI Number
- 3003757840
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10711 CAMBIE ROAD
- City
- RICHMOND British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K171121
Owner / Operator
- Firm Name
- Change Healthcare Canada Company
- Operator Number
- 8022257
- Address
- 10711 CAMBIE ROAD
- City
- RICHMOND
- State
- British Columbia
- Postal Code
- V6X 3G5
- Country
- CA
- Correspondent
- Alona Golik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2020-12-21 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2020-12-21 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2020-12-21 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-12-21 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2020-12-21 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2020-12-21 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2020-12-21 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-12-21 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-12-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-12-21 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2020-12-21 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2020-12-21 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2020-12-21 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-12-21 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-12-21 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2020-12-21 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-12-21 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2020-12-21 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2020-12-21 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2020-12-21 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2020-12-21 |
Proprietary Names
ISA CO2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device