510(k) K963068 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CTS-200 WITH EZU-PL21 TRANSDUCER
| Applicant | Shantou Institute of Ultrasonic Instuments, Walnut Creek CA, US |
| Decision | Substantially Equivalent, May 29, 1997 |
| Received | Aug 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963068
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.