FDA device listing
Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System,Consona…
FDA device listing 2043718839 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System,Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System,Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System,Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic… |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K221300 |
| Product codes | ITX, IYN, IYO |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Review panels | Radiology |
| Registered establishments | Shenzhen Mindray Bio-Medical Electronics Co.,LTD, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
| Establishment registrations | 3007603826, 3009156722 |
| FEI numbers | 3007603826, 3009156722 |
| Establishment operations | Foreign Exporter, Specification Developer, 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