510(k) K250228 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
| Applicant | Esonic Technology (Wuhan) Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Apr 23, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250228
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.