510(k) K251853 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Nov 7, 2025 |
| Received | Jun 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251853
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.