510(k) K163121 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SmartUs EXT-1M/3M
| Applicant | Telemed, Vilnius, LT |
| Decision | Substantially Equivalent, Aug 10, 2017 |
| Received | Nov 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163121
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.