FDA Registration
Active
🇩🇪 Germany
Philips Medical Systems
Reg #: 3010698831
·
FEI: 3010698831
·
Expires 2025
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- GWW
- Registration Number
- 3010698831
- FEI Number
- 3010698831
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Robert-Bosch-Strasse 14
- City
- Gaertringen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K131913
Owner / Operator
- Firm Name
- GWW
- Operator Number
- 10046102
- Address
- Robert-Bosch-Strasse 14
- City
- Gaertringen
- State
- Baden-Wurttemberg
- Postal Code
- 71116
- Country
- DE
US Agent
- Business Name
- Emergo Global Consulting LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2014-02-03 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2014-02-03 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2014-02-03 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2014-02-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2014-02-03 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2014-02-03 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2014-02-03 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2014-02-03 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2014-02-03 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2014-02-03 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2014-02-03 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2014-02-03 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2014-02-03 |
Proprietary Names
Philips Medical Systems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)