510(k) K053044 ยท HKI Camera, Ophthalmic, Ac-Powered
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
| Applicant | Opto Global, Inc., Granite Bay CA, US |
| Decision | Substantially Equivalent, Jan 24, 2006 |
| Received | Oct 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053044
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.