510(k) K162783 ยท OBO Tomography, Optical Coherence
EnFocus 2300, EnFocus 4400
| Applicant | Bioptigen, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Dec 9, 2016 |
| Received | Oct 3, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162783
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.