Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210416
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided 2021-06-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Diagnostic Ultrasound System | CRIUS M10 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053016476 |
| Diagnostic Ultrasound System | M10CV | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | ITX IYN IYO | 06903053016506 |
| M9T Ultrasound system | M9T | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06944904090146 |
| Diagnostic Ultrasound System | Operus M11 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | ITX IYN IYO | 06903053016544 |
| Diagnostic Ultrasound System | M11CV | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053016520 |
| M8 Elite Portable Diagnostic Ultrasound System | M8 Elite | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06944904095653 |
| Diagnostic Ultrasound System | M10 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053016490 |
| Diagnostic Ultrasound System | Crius M11 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053016483 |
| M9 Ultrasound system | M9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06944904048567 |
| Diagnostic Ultrasound System | M9 PREMIUM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053016537 |
| Diagnostic Ultrasound System | M11 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | ITX IYN IYO | 06903053016513 |
| M9CV Ultrasound system | M9CV | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06944904090139 |