FDA Registration
Active
🇺🇸 United States
Vios Monitoring System
Reg #: 3015328411
·
FEI: 3015328411
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- Murata Vios, Inc.
- Registration Number
- 3015328411
- FEI Number
- 3015328411
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 Commerce Drive, Suite 190
- City
- Woodbury
- State
- MN
- ZIP
- 55125
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232354
Owner / Operator
- Firm Name
- Murata Vios, Inc.
- Operator Number
- 10059850
- Address
- 700 Commerce Drive, Suite 190
- City
- Woodbury
- State
- MN
- Postal Code
- 55125
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2024-10-18 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2024-10-18 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2024-10-18 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2024-10-18 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2024-10-18 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-10-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-10-18 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2024-10-18 |
Proprietary Names
Vios Monitoring System
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device