FDA Registration
Active
🇨🇦 Canada
867040 - IntelliVue Capnography Extension
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K172904
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2018-01-11 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-01-11 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2018-01-11 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2018-01-11 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2018-01-11 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2018-01-11 |
Proprietary Names
867040 - IntelliVue Capnography Extension
867041 - IntelliVue Microstream Extension
Establishment Types
Export Device to the United States But Perform No Other Operation on Device