FDA Registration
Active
🇩🇪 Germany
PHILIPS Masimo CO2 Module
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
8
Proprietary Names
5
Establishment Types
2
Classifications
8
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
- K192137
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 |
|---|---|---|---|---|---|
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2020-09-17 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2020-09-17 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2020-09-17 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2020-09-17 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2020-09-17 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2020-09-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-09-17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2020-09-17 |
Proprietary Names
PHILIPS Masimo CO2 Module
PHILIPS Masimo O3 Module
ISA CO2 Measurement Device
Masimo O3 Measurement Device
IRMA CO2 Measurement Device
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility