510(k) K152205 ยท OBO Tomography, Optical Coherence
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, May 6, 2016 |
| Received | Aug 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152205
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.