FDA Registration
Active
🇺🇸 United States
SmartLinx Vitals Plus Patient Monitoring System
Reg #: 3012251275
·
FEI: 3012251275
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Flash Global
- Registration Number
- 3012251275
- FEI Number
- 3012251275
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5653 Creekside Pkwy
- City
- Lockbourne
- State
- OH
- ZIP
- 43137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180734
Owner / Operator
- Firm Name
- Flash Global
- Operator Number
- 10051121
- Address
- 5653 Creekside Parkway
- City
- Lockbourne
- State
- OH
- Postal Code
- 43137
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-01-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-01-23 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2019-01-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-01-23 |
Proprietary Names
SmartLinx Vitals Plus Patient Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device