FDA Registration
Active
🇺🇸 United States
867040 - IntelliVue Capnography Extension
Reg #: 3012528160
·
FEI: 3012528160
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3012528160
- FEI Number
- 3012528160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1001 Murry Ridge Lane, STE A
- City
- Murrysville
- State
- PA
- ZIP
- 15668
- Country
- US
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
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
Manufacture Medical Device for Another Party (Contract Manufacturer)