510(k) K121993 ยท OBO Tomography, Optical Coherence
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
| Applicant | Heidelberg Engineering GmbH, Fairfax VA, US |
| Decision | Substantially Equivalent, Oct 25, 2012 |
| Received | Jul 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121993
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.