FDA device listing
AO USB Receiver,PressureWire Net,PW USB Receiver,Radi Analyzer Xpress Adapter 12748,Wi-box,Wi-Box AO Transmitter, Signal…
FDA device listing 1590986735 · ABBOTT LABORATORIES
Key facts
| Proprietary names | AO USB Receiver,PressureWire Net,PW USB Receiver,Radi Analyzer Xpress Adapter 12748,Wi-box,Wi-Box AO Transmitter, Signal Transmitter |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K111854 |
| Product codes | DRG |
| Device names | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2910 |
| Review panels | Cardiovascular |
| Registered establishments | St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2184149, 3005334138 |
| FEI numbers | 1000139754, 3005334138 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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