FDA device listing
Burdick ELI 280/BUR 280 Electrocardiograph,ELI 280 Electrocardiograph / ELI 280 Cardiograph,McKesson Lumeon Series…
FDA device listing 1003118657 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | Burdick ELI 280/BUR 280 Electrocardiograph,ELI 280 Electrocardiograph / ELI 280 Cardiograph,McKesson Lumeon Series Burdick ELI 280 |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Premarket submissions | K122073 |
| Product codes | DPS |
| Device names | DPS - Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2340 |
| Review panels | Cardiovascular |
| Registered establishments | WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V., WELCH ALLYN, INC. |
| Establishment registrations | 1316463, 3006087789 |
| FEI numbers | 1316463, 3006087789 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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