510(k) K003236 ยท HKI Camera, Ophthalmic, Ac-Powered
RETINADX
| Applicant | Regulatory Associates, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 2, 2000 |
| Received | Oct 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003236
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.