FDA Registration
Active
🇩🇪 Germany
EarlyVue VS30 (863380)
Reg #: 9610816
·
FEI: 3002807167
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
2
Classifications
7
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
- K190624
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 |
|---|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2019-10-30 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2019-10-30 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-10-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-10-30 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2019-10-30 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-10-30 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2019-10-30 |
Proprietary Names
EarlyVue VS30 (863380)
EarlyVue VS30 Vital Signs Monitor
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device