510(k) K123254 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ULTRASOUND SCANNER FLEX FOCUS
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Feb 13, 2013 |
| Received | Oct 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123254
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.