510(k) K883925 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
UROIMAGER
| Applicant | Ausonics Pty , Ltd., Suffield CT, US |
| Decision | Substantially Equivalent, Dec 15, 1988 |
| Received | Sep 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883925
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.