510(k) K230768 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 9, 2023 |
| Received | Mar 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230768
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.