510(k) K213862 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HD60 Series Ultrasound Diagnostic System
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd., Qingdao, CN |
| Decision | Substantially Equivalent, Jun 8, 2022 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213862
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.