510(k) K063343 ยท HLI Ophthalmoscope, Ac-Powered
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
| Applicant | Bioptigen, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Dec 13, 2006 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063343
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.