510(k) K921163 ยท HLI Ophthalmoscope, Ac-Powered
REGALTECH MAXISCOPE
| Applicant | Regaltech Pty. , Ltd., Western Australia, AU |
| Decision | Substantially Equivalent, Oct 27, 1992 |
| Received | Mar 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921163
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.