510(k) K203500 ยท HKI Camera, Ophthalmic, Ac-Powered
RetCam Envision
| Applicant | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, Apr 13, 2021 |
| Received | Nov 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203500
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.