510(k) K260846 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Di
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 11, 2026 |
| Received | Mar 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260846
No recall in the FDA data names this 510(k).
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