510(k) K180408 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
U60 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 13, 2018 |
| Received | Feb 14, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180408
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.