510(k) K182648 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
X5 Series Digital Color Doppler Ultrasound System
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 29, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182648
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.