FDA Registration
Active
🇨🇦 Canada
IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
8
Proprietary Names
2
Establishment Types
1
Classifications
8
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
- K151681
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 |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2015-07-23 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2015-07-23 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2015-07-23 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2015-07-23 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2015-07-23 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2015-07-23 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2015-07-23 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2015-07-23 |
Proprietary Names
IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800
G7m Module
Establishment Types
Export Device to the United States But Perform No Other Operation on Device