510(k) K111047 ยท OWN Confocal Optical Imaging
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
| Applicant | Mauna Kea Technologies, Inc., Newton PA, US |
| Decision | Substantially Equivalent, Aug 8, 2011 |
| Received | Apr 15, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111047
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.