510(k) K123209 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SOFTVUE
| Applicant | Delphinus Medical Technologies, Inc., Plymouth MI, US |
| Decision | Substantially Equivalent, Dec 19, 2013 |
| Received | Oct 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123209
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.