FDA device listing
Catheter, Oximeter, Fiber-Optic
FDA device listing 1373951733 · BENCHMARK ELECTRONICS, INC.
Key facts
| Owner/operator | BENCHMARK ELECTRONICS, INC. |
|---|---|
| Owner/operator number | 1641405 |
| Product codes | DQE, DQK, DSB, DXN, FLL, MUD, QAQ, QMS |
| Device names | DQE - Catheter, Oximeter, Fiber-Optic, DQK - Computer, Diagnostic, Programmable, DSB - Plethysmograph, Impedance, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MUD - Oximeter, Tissue Saturation, QAQ - Adjunctive Predictive Cardiovascular Indicator, QMS - Adjunctive Open Loop Fluid Therapy Recommender |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130, 870.1230, 870.1425, 870.2210, 870.2700, 870.2770, 870.5600, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | BENCHMARK ELECTRONICS, INC., BENCHMARK ELECTRONICS San Jorge |
| Establishment registrations | 2133641, 3037724692 |
| FEI numbers | 3000203466, 3037724692 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database