FDA Registration
Active
🇨🇦 Canada
IntelliVue Guardian Software
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
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
- K111905
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 |
|---|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2011-10-10 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2011-10-10 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2011-10-10 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2011-10-10 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2011-10-10 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2011-10-10 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2011-10-10 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2011-10-10 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2011-10-10 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2011-10-10 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2011-10-10 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2011-10-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2011-10-10 |
Proprietary Names
IntelliVue Guardian Software
Establishment Types
Export Device to the United States But Perform No Other Operation on Device