510(k) K132800 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
SKINTELL
| Applicant | Agfa Healthcare N.V., Greenville SC, US |
| Decision | Substantially Equivalent, Mar 3, 2014 |
| Received | Sep 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132800
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.