510(k) K994385 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
BABY FACE
| Applicant | Sonora Medical Systems, Longmont CO, US |
| Decision | Substantially Equivalent, Mar 16, 2000 |
| Received | Dec 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994385
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.