510(k) K143396 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
omni TRAX Active Patient Tracker
| Applicant | Civco Medical Instruments CO Inc Dba Civco Medical Solutions, Kalona IA, US |
| Decision | Substantially Equivalent, Jan 23, 2015 |
| Received | Nov 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143396
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.