510(k) K112255 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
AIXPLORER
| Applicant | Supersonic Imagine, Aix En Provence, FR |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | Aug 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112255
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.