510(k) K912397 ยท HLI Ophthalmoscope, Ac-Powered
PROFESSIONAL INDIRECT OPHTHALMOSCOPE
| Applicant | Clement Clarke, Inc., England, GB |
| Decision | Substantially Equivalent, Oct 23, 1991 |
| Received | May 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912397
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.