510(k) K132346 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRASOUND SCANNER PRO FOCUS 2202
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Jan 10, 2014 |
| Received | Jul 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132346
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.