510(k) K100345 ยท ODA Endoscopic Central Control Unit
SYSTEMS INTEGRATION MODEL: ENDOALPHA
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 22, 2010 |
| Received | Feb 5, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100345
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.