510(k) K963863 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
JANUS I
| Applicant | 3D Ultrasound, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Sep 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963863
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.