510(k) K172380 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
U2 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Aug 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172380
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.