FDA Registration
Active
🇺🇸 United States
BENCHMARK ELECTRONICS, INC.
Reg #: 2133641
·
FEI: 3000203466
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- BENCHMARK ELECTRONICS, INC.
- Registration Number
- 2133641
- FEI Number
- 3000203466
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4065 THEURER BLVD.
- City
- WINONA
- State
- MN
- ZIP
- 55987
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232294
Owner / Operator
- Firm Name
- BENCHMARK ELECTRONICS, INC.
- Operator Number
- 1641405
- Address
- 56 S Rockford Dr., --
- City
- Tempe
- State
- AZ
- Postal Code
- 85288
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2024-09-25 |
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | Class 2 | Cardiovascular | No | 2024-09-25 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2024-09-25 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-09-25 |
| Adjunctive Predictive Cardiovascular Indicator | QAQ | Class 2 | Cardiovascular | No | 2024-09-25 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2024-09-25 |
| Adjunctive Open Loop Fluid Therapy Recommender | QMS | Class 2 | Cardiovascular | No | 2024-09-25 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-09-25 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-09-25 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)