510(k) K061278 ยท HLJ Ophthalmoscope, Battery-Powered
OPTYSE OPHTHALMOSCOPE
| Applicant | Ophthalmos , Ltd., Ickleton, Cambridge, GB |
| Decision | Substantially Equivalent, May 16, 2006 |
| Received | May 8, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061278
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.