FDA device listing
Apogee 2100 Plus with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1,Apogee 2100 with…
FDA device listing 1255926679 · SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
Key facts
| Proprietary names | Apogee 2100 Plus with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1,Apogee 2100 with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1,Apogee 2300 with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1 |
|---|---|
| Owner/operator | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
| Owner/operator number | 9011618 |
| Premarket submissions | K173000 |
| 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 | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
| Establishment registrations | 9615439, 3017944270 |
| FEI numbers | 3003861317, 3017944270 |
| 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