FDA device listing
MATRIX HOLTER SYSTEM
FDA device listing 1214043554 · GLOBAL INSTRUMENTATION, LLC
Key facts
| Proprietary names | MATRIX HOLTER SYSTEM |
|---|---|
| Owner/operator | GLOBAL INSTRUMENTATION, LLC |
| Owner/operator number | 9074706 |
| Premarket submissions | K051730 |
| Product codes | MLO |
| Device names | MLO - Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2800 |
| Review panels | Cardiovascular |
| Registered establishments | GLOBAL INSTRUMENTATION, LLC |
| Establishment registrations | 3005737664 |
| FEI numbers | 3005737664 |
| Establishment operations | Manufacturer |
| 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