510(k) K232895 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
B-Ultrasound Diagnostic System
| Applicant | Contec Medical Systems Co.,Ltd, Qinhuangdao, CN |
| Decision | Substantially Equivalent, May 3, 2024 |
| Received | Sep 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232895
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.