510(k) K213009 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Transcranial Doppler Ultrasound System
| Applicant | Shenzhen Delica Medical Equipment Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | Sep 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213009
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.