510(k) K180737 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound Scanner System bk2300
| Applicant | Bk Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Aug 1, 2018 |
| Received | Mar 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180737
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.