FDA Registration
Active
🇩🇪 Germany
Mindray Patient Monitoring System
Reg #: 3004977335
·
FEI: 3004977335
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Siemens Healthineers AG
- Registration Number
- 3004977335
- FEI Number
- 3004977335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SIEMENSSTRASSE 1 -OR-, Rittigfeld 1
- City
- FORCHHEIM Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K200015
Owner / Operator
- Firm Name
- Siemens Healthineers AG
- Operator Number
- 8010024
- Address
- Karlheinz-Kaske-Str. 5, --
- City
- Erlangen
- State
- DE-NOTA
- Postal Code
- 91052
- Country
- DE
US Agent
- Business Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Contact Name
- Robert Phillips
- Address
- 40 Liberty Boulevard
- City
- MALVERN
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 302 2359839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-05-18 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2023-05-18 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2023-05-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-05-18 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2023-05-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-05-18 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-05-18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2023-05-18 |
Proprietary Names
Mindray Patient Monitoring System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device