510(k) K011095 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
| Applicant | Iodp SA, Deer Field IL, US |
| Decision | Substantially Equivalent, Jun 13, 2001 |
| Received | Apr 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011095
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.