510(k) K012084 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONOREAL 3D
| Applicant | Bio Medi Com, Indianpolis IN, US |
| Decision | Substantially Equivalent, Sep 26, 2001 |
| Received | Jul 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012084
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.