510(k) K991284 ยท MXK Device, Analysis, Anterior Segment
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Aug 6, 1999 |
| Received | Apr 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991284
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.