510(k) K101223 ยท OBO Tomography, Optical Coherence
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
| Applicant | Heidelberg Engineering, Washington DC, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | May 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101223
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.