FDA device listing
EnSite™ LiveView Dynamic Display Software License,EnSite Precision™ Software Installation v2.6,EnSite Precision™…
FDA device listing 1071867675 · ABBOTT LABORATORIES
Key facts
| Proprietary names | EnSite™ LiveView Dynamic Display Software License,EnSite Precision™ Software Installation v2.6,EnSite Precision™ Software Installation v.2.7 H702701,EnSite Precision™ Software Upgrade v2.7.1,EnSite Precision™ System Software Upgrade v.2.6.1, H702602 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K201148 |
| Product codes | DQK |
| Device names | DQK - Computer, Diagnostic, Programmable |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1425 |
| Review panels | Cardiovascular |
| Registered establishments | St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc., St. Jude Medical Coordination Center BVBA European Distribution Center |
| Establishment registrations | 2184149, 3005334138, 3012179728, 3012552532 |
| FEI numbers | 1000139754, 3005334138, 3012179728, 3012552532 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Repackager/Relabeler, 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