510(k) K063378 ยท HLI Ophthalmoscope, Ac-Powered
CIRRUS HD-OCT, MODEL 4000
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Jan 26, 2007 |
| Received | Nov 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063378
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.