510(k) K161960 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
bk2300
| Applicant | Bk Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Oct 17, 2016 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161960
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.