FDA Registration
Active
🇺🇸 United States
HemoSphere ClearSIght Module
Reg #: 2015691
·
FEI: 2015691
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- EDWARDS LIFESCIENCES LLC
- Registration Number
- 2015691
- FEI Number
- 2015691
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- ONE EDWARDS WAY
- City
- IRVINE
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203687
Owner / Operator
- Firm Name
- Edwards Lifesciences LLC
- Operator Number
- 9040666
- Address
- One Edwards Way
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Denny Kouri
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2021-10-29 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2021-10-29 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2021-10-29 |
| Adjunctive Predictive Cardiovascular Indicator | QAQ | Class 2 | Cardiovascular | No | 2021-10-29 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2021-10-29 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-10-29 |
Proprietary Names
HemoSphere ClearSIght Module
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility