510(k) K131489 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
| Applicant | Tractus Corporation, Buffalo MN, US |
| Decision | Substantially Equivalent, Jun 25, 2013 |
| Received | May 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131489
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.