510(k) K951728 ยท HLI Ophthalmoscope, Ac-Powered
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
| Applicant | Mira, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Apr 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951728
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.