Medical Device Manufacturer · CN , Shantou

Shantou Institute of Ultrasonic Instruments Co., Ltd. - FDA 510(k) Cl...

2 submissions · 2 cleared · Since 2024

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shantou Institute of Ultrasonic Instruments Co., Ltd. Radiology ✕

2 devices

1-2 of 2

Cleared Mar 31, 2025

Digital Color Doppler Ultrasound Imaging System (Apogee C1)

Radiology · 182d

Cleared Dec 10, 2024

Digital Color Doppler Ultrasound Imaging System (Readius L15)

Radiology · 71d