FDA device listing
Merlin.net VDE MN7000 with AI
FDA device listing 1925374185 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Merlin.net VDE MN7000 with AI |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K251221 |
| Product codes | MXD |
| Device names | MXD - Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025 |
| Review panels | Cardiovascular |
| Registered establishments | ABBOTT MEDICAL |
| Establishment registrations | 2017865 |
| FEI numbers | 2017865 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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