510(k) K120057 ยท HLI Ophthalmoscope, Ac-Powered
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
| Applicant | Bioptigen, Inc., Durham NC, US |
| Decision | Substantially Equivalent, May 11, 2012 |
| Received | Jan 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120057
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.