FDA Registration
Active
🇺🇸 United States
867033, IntelliVue Patient Monitor MX100
Reg #: 3012528160
·
FEI: 3012528160
·
Expires 2025
Products
8
Proprietary Names
6
Establishment Types
1
Classifications
8
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
- K171801
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-10-17 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2017-10-17 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2017-10-17 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2017-10-17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2017-10-17 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-10-17 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2017-10-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-10-17 |
Proprietary Names
867033, IntelliVue Patient Monitor MX100
453564588501, Transpac IV Dual IBP Cable
867039, IntelliVue Hemodynamic Extension
867030, IntelliVue Multi-Measurement Module X3
867043, IntelliVue Dock
989803199741, Dual IBP Adapter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)