510(k) K854389 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
NIDEK US-1600 A-SCAN
| Applicant | Nidek, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Apr 8, 1986 |
| Received | Oct 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854389
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.