510(k) K083728 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
INVISION SYSTEM
| Applicant | Inneroptic Technology, Inc., Hillsborough NC, US |
| Decision | Substantially Equivalent, Aug 12, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083728
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.