FDA Registration
Active
🇺🇸 United States
ViSi Mobile Monitoring System
Reg #: 3009673645
·
FEI: 3009673645
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SOTERA WIRELESS
- Registration Number
- 3009673645
- FEI Number
- 3009673645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5841 Edison Place, Suite #140
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112478
Owner / Operator
- Firm Name
- Sotera Wireless, Inc.
- Operator Number
- 10040989
- Address
- 5841 Edison Place, Suite #140
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Andrew Nguyen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-06-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2012-06-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-06-08 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2012-06-08 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2012-06-08 |
Proprietary Names
ViSi Mobile Monitoring System
Establishment Types
Manufacture Medical Device