510(k) K081154 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Apr 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081154
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.