FDA Registration
Active
🇩🇪 Germany
Diverse Specialized Accessories and IntelliVue CL 865220 charging station
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
13
Proprietary Names
12
Establishment Types
1
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
- K101600
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 |
|---|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2010-10-19 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2010-10-19 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2010-10-19 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2010-10-19 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2010-10-19 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2010-10-19 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2010-10-19 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2010-10-19 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2010-10-19 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2010-10-19 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2010-10-19 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2010-10-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2010-10-19 |
Proprietary Names
Diverse Specialized Accessories and IntelliVue CL 865220 charging station
989803163211 Mobile CL Reusable Large Adult Cuff
989803163221 Mobile CL Disposable Large Adult Cuff
IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H1
IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D
989803163201 Mobile CL Disposable Adult Cuff
IntelliVue Multi-Measurement Module X2, SW Rev. H1
989803163191 Mobile CL Reusable Adult Cuff
989803163181 Mobile CL Disposable Small Adult Cuff
IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A
989803168881 Mobile CL Transmitter Cradles
989803163251 Mobile CL NBP Cradle Kit
Establishment Types
Manufacture Medical Device