FDA Registration
Active
🇩🇪 Germany
IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
13
Proprietary Names
4
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Philips Medizin Systeme Boeblingen GmbH
- Registration Number
- 9610816
- FEI Number
- 3002807167
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HEWLETT-PACKARD STRASSE 2
- City
- BOEBLINGEN Baden-Wurttemberg
- Country
- DE
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
- Deborah Currlin
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
- [email protected]
- Phone
- 858 9452753
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
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device