510(k) K163427 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 3, 2017 |
| Received | Dec 6, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163427
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.