FDA Registration
Active
🇨🇦 Canada
IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
13
Proprietary Names
4
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
- K131913
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 |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2014-12-12 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-12-12 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2014-12-12 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2014-12-12 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2014-12-12 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2014-12-12 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2014-12-12 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2014-12-12 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2014-12-12 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2014-12-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2014-12-12 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2014-12-12 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-12-12 |
Proprietary Names
IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20
IntelliVue CL SpO2 Pod
CL NBP Pod SW Rev. B2
Mobile CL Adult Bayonet Air Hose 1m
Establishment Types
Export Device to the United States But Perform No Other Operation on Device