510(k) K180461 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Navi e/Navi s/Navi X Diagnostic Ultrasound System
| Applicant | Shenzhen Wisonic Medical Technology Co. , Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 9, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180461
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.