510(k) K952551 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
JANUS I
| Applicant | 3D Ultrasound, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Dec 11, 1995 |
| Received | Jun 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952551
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.